Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-02 @ 6:43 PM
Study NCT ID:
NCT01921920
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2013-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prilosec Bioequivalence Study in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2013-08-05', 'studyFirstSubmitQcDate': '2013-08-12', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'AUC'}, {'measure': 'Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'AUC'}, {'measure': 'Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'AUC (0-t)'}, {'measure': 'Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'Cmax'}, {'measure': 'Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'AUC(0-t)'}, {'measure': 'Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'Cmax'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'Cmax'}, {'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'Cmax'}, {'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 't1/2'}, {'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'tmax'}, {'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'AUC(0-t)'}, {'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'AUC'}, {'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'λz'}, {'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'tmax'}, {'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'AUC(0-t)'}, {'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'AUC'}, {'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 'λz'}, {'measure': 'Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole', 'timeFrame': 'predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.', 'description': 't1/2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Omeprazole, Prilosec, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence'], 'conditions': ['Bioequivalence, AUC, Cmax, Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose Bioequivalence Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules Manufactured by AstraZeneca with Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female volunteers aged 18 to 50 years, inclusive, with suitable veins for cannulation or repeated venepuncture.\n* Female could be of nonchildbearing potential (postmenopausal or irreversible surgical sterilization) and childbearing potential (negative pregnancy test at screening and use 2 effective methods of avoiding pregnancy).\n* Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and a weight of at least 50 kg and no more than 100 kg, inclusive.\n\nExclusion Criteria:\n\n* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.\n* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).\n* Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.\n* Moderate to heavy smokers (more than 10 cigarettes per day or equivalent in tobacco-containing products).'}, 'identificationModule': {'nctId': 'NCT01921920', 'briefTitle': 'Prilosec Bioequivalence Study in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-label, Randomized, Single-center, 4-way Crossover, Single Dose Bioequivalence Study Comparing Omeprazole 20 and 40-mg Aqueous Solvent Based Capsules Manufactured by AstraZeneca With Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck', 'orgStudyIdInfo': {'id': 'D9584C00010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omeprazole 20mg aqueous', 'description': 'Treatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca - test)', 'interventionNames': ['Drug: Omeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omeprazole 20mg organic', 'description': 'Treatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck - reference for Treatment A)', 'interventionNames': ['Drug: Omeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omeprazole 40mg aqueous', 'description': 'Treatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca - test)', 'interventionNames': ['Drug: Omeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omeprazole 40mg organic', 'description': 'Treatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck - reference for Treatment C)', 'interventionNames': ['Drug: Omeprazole']}], 'interventions': [{'name': 'Omeprazole', 'type': 'DRUG', 'otherNames': ['Prilosec'], 'description': 'Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)', 'armGroupLabels': ['Omeprazole 20mg aqueous', 'Omeprazole 20mg organic', 'Omeprazole 40mg aqueous', 'Omeprazole 40mg organic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'David Mathews, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles Phase I unit, Kansas'}, {'name': 'Helen Lunde, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}