Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 6:53 PM
Study NCT ID:
NCT01100060
Status:
COMPLETED
Last Update Posted:
2010-08-25
First Post:
2010-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D008863', 'term': 'Microspheres'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D002738', 'term': 'Chloroquine'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-24', 'studyFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2010-04-06', 'lastUpdatePostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast of azithromycin and chloroquine', 'timeFrame': 'Through Day 5'}], 'secondaryOutcomes': [{'measure': 'Tmax and Cmax of azithromycin and chloroquine.', 'timeFrame': 'Through Day 5'}, {'measure': 'AUClast, Tmax, and Cmax of desethylchloroquine.', 'timeFrame': 'Through Day 5'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Azithromycin', 'chloroquine', 'microsphere', 'pharmacokinetics', 'bioavailability'], 'conditions': ['Malaria Prophylaxis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661195&StudyName=A%20Phase%201%20Study%20To%20Estimate%20The%20Relative%20Bioavailability%20Of%20Co-Administered%20Formulations%20Of%20Azithromycin%20Microsphere%20And%20Chloroquine%20Test%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Estimate the relative bioavailability of co-administered azithromycin microsphere (2000 mg) and the chloroquine (620 mg CQ base) test formulation compared to co-administered immediate release individual tablets of azithromycin (2000 mg) and chloroquine (600 mg CQ base) in healthy adult subjects.', 'detailedDescription': 'Evaluate the relative bioavailability, assessment of the safety and tolerability of azithromycin microsphere and the chloroquine test formulation compared to immediate release individual tablets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs).\n* An informed consent document signed and dated by the subject or a legally acceptable representative.\n* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).\n* History of febrile illness within 5 days prior to first dose.\n* Treatment with azithromycin within the past 30 days or with chloroquine within the past 45 days.\n* Known immediate family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death. "Immediate" is considered "first degree".\n* Known allergy to macrolide antibiotics (eg, erythromycin, clarithromycin, azithromycin) or chloroquine (or other 4 aminoquinolines) or severe allergic reaction to any drug in the past (eg, difficulty breathing, anaphylaxis).\n* History of intolerance to azithromycin or chloroquine.'}, 'identificationModule': {'nctId': 'NCT01100060', 'acronym': 'AZCQ', 'briefTitle': 'A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open-Label, Randomized, Single Dose, Parallel Design Study To Estimate The Relative Bioavailability Of Co Administered Formulations Of Azithromycin Microsphere (AZ) And Chloroquine Test Formulation (CQ) Compared With Co Administered Immediate Release Individual AZ And CQ Tablets In Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'A0661195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Co-administer the test chloroquine (CQ) formulation (620 mg CQ base) plus microsphere azithromycin (AZ) (2000 mg) on Day 1.', 'interventionNames': ['Drug: azithromycin (AZ) microsphere', 'Drug: test chloroquine (CQ) formulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Co-administer the individual tablets of CQ 2 x 500 mg (600 mg CQ base) tablets plus AZ IR 4 x 500 mg tablets on Day 1.', 'interventionNames': ['Drug: azithromycin (AZ)', 'Drug: chloroquine (CQ)']}], 'interventions': [{'name': 'azithromycin (AZ) microsphere', 'type': 'DRUG', 'otherNames': ['Zmax'], 'description': 'AZ microsphere (2000 mg) single dose on Day 1.', 'armGroupLabels': ['Group 1']}, {'name': 'test chloroquine (CQ) formulation', 'type': 'DRUG', 'description': 'Test CQ formulation, 620 mg CQ base, single dose on Day 1.', 'armGroupLabels': ['Group 1']}, {'name': 'azithromycin (AZ)', 'type': 'DRUG', 'otherNames': ['Zithromax'], 'description': 'AZ IR 4 x 500 mg tablets, single dose on Day 1.', 'armGroupLabels': ['Group 2']}, {'name': 'chloroquine (CQ)', 'type': 'DRUG', 'otherNames': ['Aralen'], 'description': 'CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}