Result of Bioequivalence studies of combined-formulation tablet of lamivudine/ne

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A combined-formulation tablet of lamivudine/nevirapine/stavudine:

bioequivalence compared with concurrent administration of

Lamivudine, nevirapine, and Stavudine in healthy Indian subjects

J Clin Pharmacol 2005 Mar;45(3):265-74 (ISSN: 0091-2700)

Narang VS; Lulla A; Malhotra G; Purandare S

Cipla Ltd, Mumbai Central 400008, Mumbai, India.

Generic fixed-dose combinations of antiretrovirals are frequently

prescribed for the treatment of human immunodeficiency virus

infection. A randomized, 2-way study was conducted in 24 fasting,

healthy, Indian male subjects to assess bioequivalence between a

single combination tablet containing lamivudine, stavudine, and

nevirapine (treatment A) with respect to separate marketed tablets

administered simultaneously (treatment . Each subject received

treatments A and B separated by 19 days of a drug-free washout

period.

Plasma concentrations of antiretrovirals, determined by a validated

liquid chromatography/tandem mass spectrometry assay, were used to

assess pharmacokinetic parameters such as maximum observed plasma

concentration and area under the plasma concentration curve.

Pharmacokinetic parameters were comparable for either treatment. As

geometric mean ratios (% treatment A/treatment of log-transformed

parameters of area under the plasma concentration curve and plasma

concentration, as well as their resultant 90% confidence intervals,

were within 80% to 125% and 75% to 133%, respectively, 2 treatments

were considered bioequivalent in the extent and rate of absorption.

Both treatments exhibited similar tolerability under fasting

conditions.