Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-03-06 @ 3:00 AM
Study NCT ID:
NCT02680132
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
2016-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Torrent Pharmaceutical Ltd's Esomeprazole Magnesium Delayed Release Capsules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'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': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-08', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-02-08', 'lastUpdatePostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Pre dose to 24 hour post dose', 'description': 'Pharmacokinetic Evaluation'}, {'measure': 'AUC', 'timeFrame': 'Pre dose to 24 hour post dose', 'description': 'Pharmacokinetic Evaluation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Delayed Release Capsule 1 × 40 mg and Nexium 1× 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 7 days.", 'detailedDescription': 'An Open Label, Randomized, 2 -Period, 2-Treatment, 2 Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Delayed Release Capsule 40 mg \\[Test Formulation, Torrent Pharmaceutical Ltd., India\\]Versus Nexium 40 mg Delayed Release Capsule containing Esomeprazole 40 mg. \\[Reference Formulation, AastraZeneca LP, USA\\] in Healthy Human Volunteers Under Fed Conditions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: male\n* Age: 18-45 years\n* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.\n* Healthy and willing to participate in the study.\n* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.\n* Non-smokers or smoker who smokes less than 10 cigarettes per day.\n\nExclusion Criteria:\n\n* Inability to communicate or co-operate.\n* Administration of any study drug in the period 0 to 3 months before entry to the study,\n* History of significant blood loss due to any reason, including blood donation in the past 3 months.\n* Volunteers suffering from any chronic illness such as arthritis, asthma etc.\n* History of pre-existing bleeding disorder.\n* Clinically relevant abnormalities in the results of the laboratory screening evaluation.\n* Clinically significant abnormal ECG or Chest X-ray.\n* HIV, HCV, HBsAg positive volunteers.\n* History of alcohol or drug abuse.\n* History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study.\n* Positive to Breath alcohol test.\n* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.\n* Systolic blood pressure less than 100 mmHg or more than 140 mmHg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.\n* Pulse rate less than 50/minute or more than 100/minute.\n* Oral temperature less than 35°C or more than 37.5°C.\n* Respiratory rate less than 12/minute or more than 20/minute.\n* History of allergy to the test drug or any drug chemically similar to the drug under investigation.\n* Recent History of kidney or liver dysfunction.\n* Volunteers suffering from any psychiatric (acute or chronic) disorder.\n* Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.'}, 'identificationModule': {'nctId': 'NCT02680132', 'briefTitle': "Bioequivalence Study of Torrent Pharmaceutical Ltd's Esomeprazole Magnesium Delayed Release Capsules", 'organization': {'class': 'INDUSTRY', 'fullName': 'Torrent Pharmaceuticals Limited'}, 'officialTitle': 'An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Esomeprazole Mg DR Capsule 40 mg [Torrent,India] Versus Nexium 40 mg DR Capsule [ AastraZeneca LP, USA] in Healthy Subjects-Fed Condition', 'orgStudyIdInfo': {'id': 'PK-10-180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': "Torrent's Esomeprazole Magnesium DR Capsules 40 mg", 'interventionNames': ["Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'description': 'Nexium 40 mg DR Capsules of AstraZeneca LP, USA', 'interventionNames': ['Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA']}], 'interventions': [{'name': 'Nexium 40 mg DR Capsules of AstraZeneca LP, USA', 'type': 'DRUG', 'otherNames': ['esomeprazole magnesium delayed release capsules'], 'description': 'oral, cross over', 'armGroupLabels': ['Reference']}, {'name': "Torrent's Esomeprazole Magnesium DR Capsules 40 mg", 'type': 'DRUG', 'otherNames': ['esomeprazole magnesium delayed release capsules'], 'description': 'oral, cross over', 'armGroupLabels': ['Test']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Torrent Pharmaceuticals Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}