Bioequivalence Study of Sertraline Hydrochloride 100mg Tablets Under Fasting Conditions
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|ClinicalTrials.gov Identifier: NCT00779350|
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : October 24, 2008
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: sertraline 100 mg tablets||Not Applicable|
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 fasting conditions. The study was conducted with 36 (30 completing) healthy adults in accordance with protocol No.
10540323(Revision 0). In each study period, a single 100 mg dose was administered to the subjects following an overnight fast of at least 10 hours. The test formulation was Ranbaxy Research Laboratories'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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Compare the Relative Bioavailability of Ranbaxy and Pfizer Formulations of Sertraline 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions.|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||October 2005|
sertraline 100 mg tablets of ranbaxy
Drug: sertraline 100 mg tablets
Active Comparator: 2
Zoloft® 100 mg tablets
Drug: sertraline 100 mg tablets
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779350
|United States, Pennsylvania|
|Novum Pharmaceutical Research Services|
|Pittsburgh, Pennsylvania, United States, 15206|