Comparative bioavailability of two sertraline tablet formulations after single-dose administration in healthy Thai volunteers

To compare the bioavailability of two sertraline tablet (50 mg) formulations (Serlift from Ranbaxy Laboratories Ltd., Gurgaon Haryana, India, as a test formulation and Zoloft from Pfizer Australia Pty Ltd., West Ryde, New South Wales, Australia, as a reference formulation) in 24 healthy Thai male vo...

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Published in:	International journal of clinical pharmacology and therapeutics Vol. 46; no. 3; pp. 151 - 156
Main Authors:	Tassaneeyakul, W, Kanchanawat, S, Gaysonsiri, D, Vannaprasath, S, Paupairoj, P, Kittiwattanagul, K, Tippabhotla, S K, Khuroo, A, Panigrahy, B K, Reyar, S, Monif, T
Format:	Journal Article
Language:	English
Published:	Germany 01-03-2008
Subjects:	Adult Antidepressive Agents - blood Antidepressive Agents - pharmacokinetics Area Under Curve Biological Availability Chemistry, Pharmaceutical Cross-Over Studies Half-Life Humans Male Metabolic Clearance Rate Sertraline - blood Sertraline - pharmacokinetics Thailand Thailand
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Summary:	To compare the bioavailability of two sertraline tablet (50 mg) formulations (Serlift from Ranbaxy Laboratories Ltd., Gurgaon Haryana, India, as a test formulation and Zoloft from Pfizer Australia Pty Ltd., West Ryde, New South Wales, Australia, as a reference formulation) in 24 healthy Thai male volunteers under fasting condition. A randomized, 2-treatment, 2-period, 2-sequence, single-dose, crossover study with a washout period of 3 weeks, was conducted in 24 healthy Thai male volunteers. Blood samples were collected at 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours following drug administration. Plasma concentrations of sertraline were determined using validated LC-MS/MS method. Noncompartmental pharmacokinetics and statistical analyses were performed using SAS software for Windows, release 9.1 (SAS Institute Inc., Cary, NC, USA). The ratio of least square means and the 90% confidence intervals (CI) of the log-transformed data were 0.9950 (0.9111-1.0866) for Cmax, 1.0153 (0.9576-1.0764) for AUC(0-t) and 1.0110 (0.9510-1.0747) for AUC(0-infinity). In addition, the median tmax values for the test and reference formulations were similar (5.00 h). The 90% CI for Cmax, AUC(0-t) and AUC(0-infinity) were within the 0.8-1.25 interval of the US-FDA. The test formulation (Serlift, Ranbaxy Laboratories Ltd., Gurgaon, Haryana, India) is bioequivalent to the reference formulation (Zoloft, Pfizer Australia Pty Ltd., West Ryde, New South Wales, Australia) both in terms of rate and extent of absorption after single-dose administration under fasting condition.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23
ISSN:	0946-1965
DOI:	10.5414/CPP46151