title: Bioequivalence study of two tablet formulations containing rimonabant 20 mg in healthy Indian subjects.
abstract: A randomized, two-treatment and two-way crossover study on twelve healthy Indian male subjects was conducted to assess the bioequivalence of two tablet formulations containing 20 mg of rimonabant (CAS 158681-13-1). Both of the formulations were administered orally as a single dose with a 45-day washout period between two dosing sessions. The content of rimonabant in plasma was determined by a validated HPLC method with UV detection. The formulations were compared using the parameters area under the plasma concentration-time curve (AUC(0-t)), area under the plasma concentration-time curve from zero to infinity (AUC(0-infinity)), peak plasma concentration (Cmax), and time to reach peak plasma concentration (tmax). The results of this investigation indicated that there were no statistically significant differences between the logarithmically transformed AUC(0-infinity) and Cmax values of the two preparations. The 90% confidence interval for the ratio of the logarithmically transformed AUC(0-t), AUC(0-infinity) and Cmax were within the bioequivalence limit of 0.8-1.25 and the relative bioavailability of the test formulation was 96.62% of that of the reference formulation. Thus, these findings clearly indicate that the two formulations are bioequivalent in terms of rate and extent of drug absorption.
authors.affiliation: Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
authors.forename: Utpal
authors.initials: U
authors.lastname: Nandi
authors.forename: Uttam
authors.initials: U
authors.lastname: Bhaumik
authors.forename: Uday S
authors.initials: US
authors.lastname: Chakrabarty
authors.forename: Ayan
authors.initials: A
authors.lastname: Das
authors.forename: Tapan K
authors.initials: TK
authors.lastname: Pal
mesh_terms: D000293:Adolescent; D000328:Adult; D019440:Anti-Obesity Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006801:Humans; D007194:India; D007202:Indicators and Reagents; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage / Q000493:pharmacokinetics*; D011720:Pyrazoles / Q000008:administration & dosage / Q000493:pharmacokinetics*; D015203:Reproducibility of Results; D000077285:Rimonabant; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D019440:Anti-Obesity Agents; D007202:Indicators and Reagents; D010880:Piperidines; D011720:Pyrazoles; D013607:Tablets; D000077285:Rimonabant