Abstract

Objective: The objective of the study was to compare the bioequivalence of a fixed-dose combination of a nevirapine 200 mg, lamivudine 150 mg and stavudine 30 mg combination tablet with application of the 3 medications, at the same dosage, concurrently as separate formulations, in healthy, adult subjects under fasting conditions. Material and methods: An open-label, balanced, randomized, 2-treatment, 2-period, 2-sequence, single-dose, crossover bioavailability study was conducted in 40 subjects with 21-day washout period between each treatment. Blood samples were collected for 168 hours. Plasma concentrations of nevirapine, lamivudine and stavudine were determined using a validated LC-MS-MS method. Non-compartmental pharmacokinetics and statistical analyses were performed using SAS (SAS Institute Inc., Cary, NC, USA) software (SAS System under Windows, Version 8.02). Results: The ratios of least-square means and the 90% confidence intervals of the log-transformed data were calculated for AUC0-t, AUC0-inf, and Cmax. The 90% confidence interval for least-square mean ratio between test and reference formulation for log-transformed parameters Cmax, AUC0-t and AUC0-inf were within the requirements of the 80 – 125% range. Conclusion: The test formulation (Ranbaxy Laboratories Ltd., Gurgaon, India) is bioequivalent to the reference formulations both in terms of rate and extent of absorption after single-dose administration under fasting condition.

Author Details

Authors

• T. Monif¹
• S.K. Tippabhotla¹
• M. Garg²
• A.K. Singla²
• T. Vijan²

Departments

• ¹ Department of Clinical Pharmacology and Pharmacokinetics, and
• ² Department of Product Development and Research, Ranbaxy Laboratories Ltd., Gurgaon, Haryana, India

Address

T. Monif, PhD
Director, Department of Clinical Pharmacology and Pharmacokinetics
Ranbaxy Laboratories Ltd.
Plot No. 20, Sector-18
Udyog Vihar Industrial Area
Gurgaon – 122 001, Haryana, India
Email: [email protected]

Citation