Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 6:44 PM
Study NCT ID:
NCT00881634
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2009-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2009-04-13', 'studyFirstSubmitQcDate': '2009-04-14', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence based on AUC and Cmax', 'timeFrame': '10 days'}]}, 'conditionsModule': {'conditions': ['Allergies']}, 'descriptionModule': {'briefSummary': 'To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '53 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.\n\nExclusion Criteria:\n\n* Positive test results for HIV or hepatitis B or C.\n* Treatment for drug or alcohol dependence.'}, 'identificationModule': {'nctId': 'NCT00881634', 'briefTitle': 'To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fed Conditions', 'orgStudyIdInfo': {'id': '2005-984'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)', 'interventionNames': ['Drug: Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)', 'interventionNames': ['Drug: Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)']}], 'interventions': [{'name': 'Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xueyu (Eric) Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharma Medica Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Eric Mittleberg, Ph.D, VP of Product Development', 'oldOrganization': 'Sandoz Inc.'}}}}