Nevirapine/lamivudine/stavudine as a combined-formulation tablet: bioequivalence study compared with each component administered concurrently under fasting condition
Monif, T.; Tippabhotla, S.K.; Garg, M.; Singla, A.K.; Vijan, T.
International Journal of Clinical Pharmacology and Therapeutics 44(6): 276-283
2006
ISSN/ISBN: 0946-1965 PMID: 16800100 Document Number: 604580
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 AUC(0-t), AUC(0-inf), and C-max. The 90% confidence interval for least-square mean ratio between test and reference formulation for log-transformed parameters C-max, AUC(0,t) and AUC(0-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.