Bioequivalence study of two capsule formulations containing diacerein 50 mg in healthy human subjects.
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.
Chakrabarty
Uday S
US
Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
Mandal
Uttam
U
Bhaumik
Uttam
U
Chatterjee
Bappaditya
B
Ghosh
Animesh
A
Bose
Anirban
A
Pal
Tapan K
TK
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
D000880:Anthraquinones; D000894:Anti-Inflammatory Agents, Non-Steroidal; D002214:Capsules; D007202:Indicators and Reagents; C025292:diacerein