Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 8:02 PM
Study NCT ID:
NCT01419366
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2011-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'lastUpdateSubmitDate': '2013-08-21', 'studyFirstSubmitDate': '2011-08-16', 'studyFirstSubmitQcDate': '2011-08-17', 'lastUpdatePostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence based on Composite of Pharmacokinetics', 'description': 'Bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Objective:\n\nTo compare the rate and extent of release of the drug substance from the two tablet formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of at least 7 days.\n\nStudy Design:\n\nRandomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The volunteers were excluded from the study based on the following 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* The volunteers were excluded from the study based on the following criteria:\n\n * Clinically relevant abnormalities in the results of the laboratory screening evaluation.\n * Clinically significant abnormal ECG or Chest X-ray.\n * Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg 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 95°P or more than 98.6°P.\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 * History of alcohol or drug abuse\n * Positive breath alcohol test\n * Recent history of kidney or liver dysfunction.\n * History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.\n * Volunteers suffering from any chronic illness such as arthritis, asthma etc.\n * History of heart failure.\n * HIV, HCV, HBsAg positive volunteers.\n * Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.\n * Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.\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 * History of pre-existing bleeding 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.\n * Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.'}, 'identificationModule': {'nctId': 'NCT01419366', 'briefTitle': "Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fed Conditions", 'organization': {'class': 'INDUSTRY', 'fullName': 'Torrent Pharmaceuticals Limited'}, 'officialTitle': 'An Open Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Donepezil Hydrochloride Tablets 10mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Aricept® (Donepezil Hydrochloride) Tablets 10mg [Reference Formulation, Eisai Inc.), in Healthy Human Volunteers Under Fed Conditions', 'orgStudyIdInfo': {'id': 'PK-07-132'}}, 'armsInterventionsModule': {'interventions': [{'name': "Torrent's Donepezil Hydrochloride Tablets 10mg", 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '382428', 'city': 'Village Bhat, Gandhinagar', 'state': 'Gujarat', 'country': 'India', 'facility': 'Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,', 'geoPoint': {'lat': 23.21667, 'lon': 72.68333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Torrent Pharmaceuticals Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Investigator', 'oldOrganization': 'Torrent Pharmaceuticals Limited'}}}}