Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-01 @ 12:28 PM
Study NCT ID:
NCT00779350
Status:
COMPLETED
Last Update Posted:
2008-10-24
First Post:
2008-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Sertraline Hydrochloride 100mg Tablets Under Fasting Conditions
Sponsor:
Ranbaxy Laboratories Limited
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 fasted conditions in healthy male and female adult subjects.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: