Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-28 @ 3:17 PM
Study NCT ID:
NCT01170169
Status:
COMPLETED
Last Update Posted:
2010-07-27
First Post:
2010-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions
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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-26', 'studyFirstSubmitDate': '2010-05-31', 'studyFirstSubmitQcDate': '2010-07-26', 'lastUpdatePostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence based on Cmax and AUC parameters', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fasting condition.", 'detailedDescription': "This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr.Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules (manufactured by Merck \\& Co., Inc., USA) in 44 healthy, adult, human subjects under fasting conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who provided written informed consent.\n* Subjects who were healthy within 18-45 years of age, weighing at least 50 kg.\n* Body mass index of ≥ 18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg.\n* Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I).\n* Subjects with normal ECG, chest X-ray (PA view) and vital signs.\n* Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.\n\nTest product, dose, mode of administration and batch number'}, 'identificationModule': {'nctId': 'NCT01170169', 'briefTitle': 'Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': "A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study to Compare Omeprazole 40 mg DR Capsules Dr. Reddy's Laboratories Ltd.,With Prilosec® 40 mg Merck & Co.Inc., USA Under Fasting Conditions", 'orgStudyIdInfo': {'id': '7566/05-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omeprazole', 'description': "Omeprazole Delayed Release Capsules of Dr. Reddy's laboratories limited", 'interventionNames': ['Drug: Omeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prilosec', 'description': 'Prilosec® 40 mg of Merck \\& Co.Inc.', 'interventionNames': ['Drug: Prilosec']}], 'interventions': [{'name': 'Omeprazole', 'type': 'DRUG', 'otherNames': ['Prelosec 40 mg'], 'description': 'Omeprazole Delayed Release Capsules 40 mg', 'armGroupLabels': ['Omeprazole']}, {'name': 'Prilosec', 'type': 'DRUG', 'description': 'Prilosec® 40 mg of Merck \\& Co.Inc.', 'armGroupLabels': ['Prilosec']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Majoj K Bose', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vimta Labs Limited, 142, IDA, Phase-II, Cherlapally, Hyderabad - India-500 051'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Assistant manager - Research & Development', 'oldOrganization': "Dr. Reddy's Laboratories Limited"}}}}