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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778973 |
The purpose of this study was to evaluate the relative bioavailability of the test formulation of sertraline 100 mg tablets with an already marketed reference formulation Zoloft® 100 mg tablets (Pfizer), under non-fasting conditions in healthy male and female adult subjects.
Condition | Intervention |
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Healthy |
Drug: sertraline 100 mg tablets |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Study to Compare the Relative Bioavailability of Ranbaxy and Pfizer Formulation of Sertraline 100 mg Tablets in Healthy Adult Volunteers Under Fed Conditions. |
Enrollment: | 36 |
Study Start Date: | August 2005 |
Study Completion Date: | October 2005 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
sertraline 100 mg tablets of Ranbaxy
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Drug: sertraline 100 mg tablets |
2: Active Comparator
Zoloft® 100 mg tablets
|
Drug: sertraline 100 mg tablets |
This randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 100 mg sertraline hydrochloride tablets under non-fasting conditions. The study was conducted with 36 (34 completing) healthy adults in accordance with protocol No.
10540324 (Revision 0). In each study period, a single 100 mg dose was administered to the subjects following a standardized high fat breakfast preceded by an overnight fast of at least 10 hours. The test formulation was Ranbaxy Research Laboratory's Sertraline Hydrochloride 100 mg Tablets and the reference formulation was ZOLOFT® (sertraline hydrochloride) 100 mg Tablets Manufactured by Roerig (Division of Pfizer). The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 14-day interval between treatments.
Blood samples were collected pre-dose and at intervals over 144 hours after each dose. The plasma samples for all subjects completing both periods of the study were sent to Helen Fassoulas, B.Sc., Director of Operations, Warnex Bioanalytical Services Inc., 3885 boul Industriel, Laval, Quebec, H7LAS3 Canada, Telephone: 450-663-6724, ext. 438, FAX: 450-975-8111 for determination of sertraline plasma concentration.
Statistical analysis was performed by Yetta I. Wilbur, Biostatistician, Novum Pharmaceutical Research Services, 5900 Penn Avenue, Pittsburgh, PA 15206, USA, Telephone: 412-363-3300, Fax: 412-362-5783 to evaluate the relative bioavailability of the test formulation to that of the reference product.
A total of 36 healthy adult subjects.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif Monif ) |
Study ID Numbers: | 10540324 |
Study First Received: | October 23, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00778973 |
Health Authority: | United States: Institutional Review Board |
Bioequivalence sertraline 100 mg tablets under fed conditions |
Malnutrition Sertraline Healthy Serotonin |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |