Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT01928069
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2013-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'lastUpdateSubmitDate': '2013-08-20', 'studyFirstSubmitDate': '2013-08-20', 'studyFirstSubmitQcDate': '2013-08-20', 'lastUpdatePostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bioequivalence based on Composite of Pharmacokinetics', 'timeFrame': 'plasma samples were obtained from blood drawn at Pre-dose and 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 14.00, 18.00 and 24.00 hours after dose administration', '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\nPrimary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet. Dosing periods were separated by a washout period during fed study.\n\nStudy Design:\n\nOpen-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe volunteers were included in 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\nThe 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': 'NCT01928069', 'briefTitle': "Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fed Conditions", 'organization': {'class': 'INDUSTRY', 'fullName': 'Torrent Pharmaceuticals Limited'}, 'officialTitle': 'An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium 10mg Tablet (Test, Torrent Pharmaceuticals Ltd., India) Versus Singulair® (Montelukast Sodium) 10 mg Tablet (Reference, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fed Condition.', 'orgStudyIdInfo': {'id': 'PK-09-198'}}, 'armsInterventionsModule': {'interventions': [{'name': "Torrent's Montelukast Sodium Tablets 10 mg", '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': {'type': 'SPONSOR'}}}}