Bioequivalence evaluation of a fixed dose combination lamivudine + stavudine tablet with concurrent administration of lamivudine tablet and stavudine capsule in healthy volunteers.
The study was designed to compare the rate and extent of absorption of a fixed dose combination tablet of lamivudine (CAS 134678-17-4) and stavudine (CAS 3056-17-5) with the concurrent administration of lamivudine tablet and stavudine capsule in 24 healthy volunteers under fasting conditions. The volunteers were randomly assigned to the test or reference treatment, with the two treatment periods separated by a washout period of at least 7 days. Plasma samples were analyzed for both analytes lamivudine and stavudine by a validated analytical method. Since the 90% confidence intervals for the "test/reference" mean ratio of the In-transformed pharmacokinetic variables C(max) AUC(0-t) and AUC(0-infinity) were clearly within the conventional bioequivalence range of 80% to 125%, the two treatments were considered bioequivalent. The safety profiles of both the test and reference formulations were comparable.
Chachad
Siddarth
S
Department of Clinical and Bioequivalence Research, Cipla Limited, Mumbai, India.
Lulla
Amar
A
Malhotra
Geena
G
Purandare
Shrinivas
S
D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004338:Drug Combinations; D005260:Female; D006801:Humans; D019259:Lamivudine / Q000493:pharmacokinetics*; D008297:Male; D018119:Stavudine / Q000493:pharmacokinetics*; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
D019380:Anti-HIV Agents; D002214:Capsules; D004338:Drug Combinations; D013607:Tablets; D019259:Lamivudine; D018119:Stavudine