Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 12:54 PM
Study NCT ID:
NCT05263895
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2022-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Relative Bioavailability Study of 4 Different Formulations of PF-07321332 Relative to the Commercial Tablet Formulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719967', 'term': 'nirmatrelvir and ritonavir drug combination'}, {'id': 'C000718217', 'term': 'nirmatrelvir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 35 days after last dose of study intervention (up to 12 weeks)', 'description': 'The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Nirmatrelvir (SDD Suspension) 300 mg', 'description': 'On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (Clast) (AUClast) of Nirmatrelvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG001', 'title': 'Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG002', 'title': 'Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG003', 'title': 'Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG004', 'title': 'Nirmatrelvir (SDD Suspension) 300 mg', 'description': 'On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).'}], 'classes': [{'categories': [{'measurements': [{'value': '35020', 'spread': '15', 'groupId': 'OG000'}, {'value': '31700', 'spread': '26', 'groupId': 'OG001'}, {'value': '35990', 'spread': '26', 'groupId': 'OG002'}, {'value': '48380', 'spread': '15', 'groupId': 'OG003'}, {'value': '10530', 'spread': '50', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Adjusted Geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '90.54', 'ciLowerLimit': '79.85', 'ciUpperLimit': '102.65', 'groupDescription': 'Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.78', 'ciLowerLimit': '90.65', 'ciUpperLimit': '116.53', 'groupDescription': 'Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '138.15', 'ciLowerLimit': '118.03', 'ciUpperLimit': '161.69', 'groupDescription': 'Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '30.8', 'ciLowerLimit': '25.70', 'ciUpperLimit': '35.20', 'groupDescription': 'Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours postdose', 'description': 'AUClast for nirmatrelvir was calculated by Linear/Log trapezoidal method. Natural log-transformed AUClast for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed AUClast for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Nirmatrelvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG001', 'title': 'Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG002', 'title': 'Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG003', 'title': 'Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG004', 'title': 'Nirmatrelvir (SDD Suspension) 300 mg', 'description': 'On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).'}], 'classes': [{'categories': [{'measurements': [{'value': '35540', 'spread': '14', 'groupId': 'OG000'}, {'value': '32430', 'spread': '26', 'groupId': 'OG001'}, {'value': '36420', 'spread': '25', 'groupId': 'OG002'}, {'value': '48680', 'spread': '15', 'groupId': 'OG003'}, {'value': '10580', 'spread': '50', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '91.26', 'ciLowerLimit': '80.46', 'ciUpperLimit': '103.51', 'groupDescription': 'Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.49', 'ciLowerLimit': '90.36', 'ciUpperLimit': '116.26', 'groupDescription': 'Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '136.99', 'ciLowerLimit': '117.09', 'ciUpperLimit': '160.27', 'groupDescription': 'Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '29.77', 'ciLowerLimit': '25.45', 'ciUpperLimit': '34.83', 'groupDescription': 'Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours postdose', 'description': 'AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. Natural log-transformed AUCinf for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed AUCinf for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Nirmatrelvir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG001', 'title': 'Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG002', 'title': 'Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG003', 'title': 'Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG004', 'title': 'Nirmatrelvir (SDD Suspension) 300 mg', 'description': 'On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).'}], 'classes': [{'categories': [{'measurements': [{'value': '3347', 'spread': '16', 'groupId': 'OG000'}, {'value': '3155', 'spread': '23', 'groupId': 'OG001'}, {'value': '3635', 'spread': '27', 'groupId': 'OG002'}, {'value': '8840', 'spread': '14', 'groupId': 'OG003'}, {'value': '4871', 'spread': '30', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.28', 'ciLowerLimit': '80.77', 'ciUpperLimit': '110.05', 'groupDescription': 'Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.60', 'ciLowerLimit': '93.04', 'ciUpperLimit': '126.76', 'groupDescription': 'Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '264.12', 'ciLowerLimit': '232.32', 'ciUpperLimit': '300.27', 'groupDescription': 'Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '145.53', 'ciLowerLimit': '128.01', 'ciUpperLimit': '165.45', 'groupDescription': 'Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours postdose', 'description': 'Cmax for nirmatrelvir was observed directly from data. Natural log-transformed Cmax for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed Cmax for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG001', 'title': 'Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG002', 'title': 'Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG003', 'title': 'Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG004', 'title': 'Nirmatrelvir (SDD Suspension) 300 mg', 'description': 'On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).'}], 'classes': [{'title': 'All-Causality AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Treatment-Related AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 35 days after last dose of study intervention (up to 12 weeks)', 'description': "An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs might arise from symptoms or other complaints reported to the investigator by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative), or they might arise from clinical findings of the investigator or other healthcare providers (clinical signs, test results, etc.). TEAEs were those with initial onset or increasing in severity after the first dose of study treatment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG001', 'title': 'Nirmatrelvir (SDD Suspension) 300 mg', 'description': 'On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).'}], 'classes': [{'title': 'Bicarbonate (mEq/L) <0.9 x LLN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (EU/dL) >=1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fibrinogen (mg/dL) >1.25 x Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'URINE Hemoglobin (Scalar) >=1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening (from Day-28 to Day-2), Day-1 of Period 1 (before 1st dose) and Day4 of Period 5 (4 days after the last dose on study discharge day). Each treatment period was 4 days long (Day1 to Day4) with a minimum of 4 days washout between each period', 'description': 'The laboratory abnormality parameters included Chemistry: bicarbonate (milliequivalents per liter \\[mEq/L\\]) \\<0.9 x lower limit of normal (LLN), urobilinogen (ehrlich units per deciliter \\[EU/dL\\]) \\>=1, and fibrinogen (milligram/deciliter \\[mg/dL\\]) \\>1.25 x baseline; Urinalysis: URINE hemoglobin (Scalar) \\>=1, only those categories in which at least 1 participant had data were reported. All the safety laboratory samples were collected following at least a 4 hour fast. Clinical laboratory evaluations only included treatments of nirmatrelvir SDD suspension/ritonavir 300/100 mg and nirmatrelvir SDD suspension 300 mg. No participant was evaluable for clinical laboratory evaluations for the other treatments.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with at least 1 observation of the given laboratory test while on study treatment or during lag time.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG001', 'title': 'Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG002', 'title': 'Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG003', 'title': 'Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG004', 'title': 'Nirmatrelvir (SDD Suspension) 300 mg', 'description': 'On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening (D28-D2), D1 of Period 1 (before 1st dose), D1 hr 0,2,and 6 of each period, and D4 of Period 5 (4 days after the last dose on study discharge day). Each treatment Period was 4 days long (D1-D4) with a minimum 4 days washout between each period', 'description': "Single supine blood pressure (BP) and pulse rate (PR) were measured with the participant's arm supported at the level of the heart and recorded to the nearest mm Hg after approximately 5 minutes of rest. The same arm (preferably the dominant arm) was used throughout the study. Participants were instructed not to speak during measurements.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ECG Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG001', 'title': 'Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG002', 'title': 'Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG003', 'title': 'Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG004', 'title': 'Nirmatrelvir (SDD Suspension) 300 mg', 'description': 'On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening (from D-28 to D-2), D1, hr0 of Period 1 (before 1st dose) and D4 of Period 5 (4 days after last dose on study discharge day). Each treatment period was 4 days long (D1 to D4) with a minimum of 4 days washout between each period', 'description': 'Standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Physical Examination Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG001', 'title': 'Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG002', 'title': 'Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG003', 'title': 'Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).'}, {'id': 'OG004', 'title': 'Nirmatrelvir (SDD Suspension) 300 mg', 'description': 'On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening (from Day-28 to Day-2), Day-1 of Period 1 (before 1st dose. Each treatment period was 4 days long (Day1 to Day4) with a minimum of 4 days washout between each period', 'description': 'A complete PE included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant reported symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1', 'description': 'Twelve participants were randomly assigned to 1 of 6 sequences. Each sequence included 2 participants who received 5 study treatments in 5 study periods.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.'}, {'id': 'FG001', 'title': 'Sequence 2', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.'}, {'id': 'FG002', 'title': 'Sequence 3', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.'}, {'id': 'FG003', 'title': 'Sequence 4', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.'}, {'id': 'FG004', 'title': 'Sequence 5', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.'}, {'id': 'FG005', 'title': 'Sequence 6', 'description': 'On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.\n\nOn Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Twelve participants were enrolled to 1 of 6 sequences. Each participant participated in 5 study periods to receive 5 treatments: Treatment A: nirmatrelvir (commercial tablets)/ritonavir 300/100 mg; Treatment B: nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg; Treatment C: nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg; Treatment D: nirmatrelvir (spray dried dispersion \\[SDD\\] suspension)/ritonavir 300/100 mg; Treatment E: nirmatrelvir 300 mg (SDD suspension)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants enrolled in this study, "Enrolled" meant a participant\'s agreement to participate in a clinical study following completion of the informed consent process and screening. Potential participants who were screened for the purpose of determining eligibility for the study, but did not participate in the study, were not considered enrolled, unless otherwise specified by the protocol. A participant was considered enrolled if the informed consent was not withdrawn prior to participating in any study activity after screening.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '62'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '18-44 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '45-64 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American, White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Race', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Ethnicity', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who took at least 1 dose of study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-08', 'size': 4008801, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-02T08:07', 'hasProtocol': True}, {'date': '2022-03-11', 'size': 2154172, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-02T08:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2022-02-25', 'resultsFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2022-02-25', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-23', 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (Clast) (AUClast) of Nirmatrelvir', 'timeFrame': '0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours postdose', 'description': 'AUClast for nirmatrelvir was calculated by Linear/Log trapezoidal method. Natural log-transformed AUClast for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed AUClast for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.'}, {'measure': 'Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Nirmatrelvir', 'timeFrame': '0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours postdose', 'description': 'AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. Natural log-transformed AUCinf for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed AUCinf for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Nirmatrelvir', 'timeFrame': '0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours postdose', 'description': 'Cmax for nirmatrelvir was observed directly from data. Natural log-transformed Cmax for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed Cmax for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline up to 35 days after last dose of study intervention (up to 12 weeks)', 'description': "An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs might arise from symptoms or other complaints reported to the investigator by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative), or they might arise from clinical findings of the investigator or other healthcare providers (clinical signs, test results, etc.). TEAEs were those with initial onset or increasing in severity after the first dose of study treatment."}, {'measure': 'Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)', 'timeFrame': 'Screening (from Day-28 to Day-2), Day-1 of Period 1 (before 1st dose) and Day4 of Period 5 (4 days after the last dose on study discharge day). Each treatment period was 4 days long (Day1 to Day4) with a minimum of 4 days washout between each period', 'description': 'The laboratory abnormality parameters included Chemistry: bicarbonate (milliequivalents per liter \\[mEq/L\\]) \\<0.9 x lower limit of normal (LLN), urobilinogen (ehrlich units per deciliter \\[EU/dL\\]) \\>=1, and fibrinogen (milligram/deciliter \\[mg/dL\\]) \\>1.25 x baseline; Urinalysis: URINE hemoglobin (Scalar) \\>=1, only those categories in which at least 1 participant had data were reported. All the safety laboratory samples were collected following at least a 4 hour fast. Clinical laboratory evaluations only included treatments of nirmatrelvir SDD suspension/ritonavir 300/100 mg and nirmatrelvir SDD suspension 300 mg. No participant was evaluable for clinical laboratory evaluations for the other treatments.'}, {'measure': 'Number of Participants With Vital Signs Abnormalities', 'timeFrame': 'Screening (D28-D2), D1 of Period 1 (before 1st dose), D1 hr 0,2,and 6 of each period, and D4 of Period 5 (4 days after the last dose on study discharge day). Each treatment Period was 4 days long (D1-D4) with a minimum 4 days washout between each period', 'description': "Single supine blood pressure (BP) and pulse rate (PR) were measured with the participant's arm supported at the level of the heart and recorded to the nearest mm Hg after approximately 5 minutes of rest. The same arm (preferably the dominant arm) was used throughout the study. Participants were instructed not to speak during measurements."}, {'measure': 'Number of Participants With ECG Abnormalities', 'timeFrame': 'Screening (from D-28 to D-2), D1, hr0 of Period 1 (before 1st dose) and D4 of Period 5 (4 days after last dose on study discharge day). Each treatment period was 4 days long (D1 to D4) with a minimum of 4 days washout between each period', 'description': 'Standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position.'}, {'measure': 'Number of Participants With Physical Examination Abnormalities', 'timeFrame': 'Screening (from Day-28 to Day-2), Day-1 of Period 1 (before 1st dose. Each treatment period was 4 days long (Day1 to Day4) with a minimum of 4 days washout between each period', 'description': 'A complete PE included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant reported symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronavirus disease 2019 (COVID-19)', 'severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)'], 'conditions': ['Bioavailability']}, 'referencesModule': {'references': [{'pmid': '37231296', 'type': 'DERIVED', 'citation': 'Sagawa K, Lin J, Jaini R, Di L. Physiologically-Based Pharmacokinetic Modeling of PAXLOVID with First-Order Absorption Kinetics. Pharm Res. 2023 Aug;40(8):1927-1938. doi: 10.1007/s11095-023-03538-5. Epub 2023 May 25.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4671008', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the relative bioavailability of PF-07321332 in different formulations in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs.\n* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lb).\n* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures\n\nExclusion Criteria:\n\n* Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n* Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome).\n* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).\n* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antibody (HCVAb). Hepatitis B vaccination is allowed.\n* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.\n* Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.\n* A positive urine drug test.'}, 'identificationModule': {'nctId': 'NCT05263895', 'briefTitle': 'Relative Bioavailability Study of 4 Different Formulations of PF-07321332 Relative to the Commercial Tablet Formulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07321332 FOLLOWING ORAL ADMINISTRATION OF 4 DIFFERENT FORMULATIONS RELATIVE TO THE COMMERCIAL TABLET FORMULATION IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS', 'orgStudyIdInfo': {'id': 'C4671008'}, 'secondaryIdInfos': [{'id': 'NCT05263895', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment A: PF-0732133/ritonavir', 'description': 'PF-07321332 ritonavir', 'interventionNames': ['Drug: PF-07321332/ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: PF-07321332/ritonavir', 'description': 'PF-07321332 ritonavir', 'interventionNames': ['Drug: PF-07321332/ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C: PF-07321332/ritonavir', 'description': 'PF-07321332 ritonavir', 'interventionNames': ['Drug: PF-07321332/ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D: PF-07321332/ritonavir', 'description': 'PF-07321332 ritonavir', 'interventionNames': ['Drug: PF-07321332/ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment E: PF-07321332', 'description': 'PF-07321332', 'interventionNames': ['Drug: PF-07321332']}], 'interventions': [{'name': 'PF-07321332/ritonavir', 'type': 'DRUG', 'description': 'PF-07321332 ritonavir will be administered as single dose orally', 'armGroupLabels': ['Treatment A: PF-0732133/ritonavir']}, {'name': 'PF-07321332/ritonavir', 'type': 'DRUG', 'description': 'PF-07321332 ritonavir will be administered as single oral dose orally.', 'armGroupLabels': ['Treatment B: PF-07321332/ritonavir']}, {'name': 'PF-07321332/ritonavir', 'type': 'DRUG', 'description': 'PF-07321332 ritonavir will be administered as single oral dose orally.', 'armGroupLabels': ['Treatment C: PF-07321332/ritonavir']}, {'name': 'PF-07321332/ritonavir', 'type': 'DRUG', 'description': 'PF-07321332 ritonavir will be administered as single oral dose orally.', 'armGroupLabels': ['Treatment D: PF-07321332/ritonavir']}, {'name': 'PF-07321332', 'type': 'DRUG', 'description': 'PF-07321332 will be administered as single oral dose orally.', 'armGroupLabels': ['Treatment E: PF-07321332']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Clinical Research Unit - New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}