title: Bioequivalence study of two capsule formulations containing diacerein 50 mg in healthy human subjects.
abstract: This study presents the results of a two-way, two-period, two-treatment crossover investigation in 12 healthy Indian male subjects to assess the bioequivalence of two oral formulations containing 50 mg of diacerein (CAS 13739-02-1). Both formulations were administered orally as a single dose separated by a one-week washout period. The content of diacerein 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 study 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 96.63% 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: Uday S
authors.initials: US
authors.lastname: Chakrabarty
authors.forename: Uttam
authors.initials: U
authors.lastname: Mandal
authors.forename: Uttam
authors.initials: U
authors.lastname: Bhaumik
authors.forename: Bappaditya
authors.initials: B
authors.lastname: Chatterjee
authors.forename: Animesh
authors.initials: A
authors.lastname: Ghosh
authors.forename: Anirban
authors.initials: A
authors.lastname: Bose
authors.forename: Tapan K
authors.initials: TK
authors.lastname: Pal
mesh_terms: D000293:Adolescent; D000328:Adult; D000880:Anthraquinones / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D005260:Female; D006801:Humans; D007202:Indicators and Reagents; D008297:Male; D008875:Middle Aged; D013056:Spectrophotometry, Ultraviolet; D013810:Therapeutic Equivalency
chemical_list: D000880:Anthraquinones; D000894:Anti-Inflammatory Agents, Non-Steroidal; D002214:Capsules; D007202:Indicators and Reagents; C025292:diacerein