Evaluation of the bioequivalence of two faropenem formulations in healthy Indian subjects.
This paper presents the results of a two-period, two-treatment, crossover study conducted in 12 Indian male volunteers under fasting conditions to assess the bioequivalence of two oral formulations (Reference and Test) containing 200 mg of faropenem (CAS 106560-14-9). Both of the formulations were administered orally as a single dose separated by a washout period of 1 week. The content of faropenem 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 (AUC0-t), area under the plasma concentration-time curve from zero to infinity (AUC0-infinity), peak plasma concentration (Cmax) and time to reach peak plasma concentration (tmax). The results Indicated that there were no statistically significant differences between the logarithmically transformed AUC0-infinity and Cmax values between the test and reference formulation. The 90% confidence interval for the ratio of the logarithmically transformed AUC0-t, AUC0-infinity and Cmax were within the bioequivalence limit of 0.8-1.25 and the relative bioavailability of the test formulation was 97.74% of that of the reference formulation.
Bhaumik
Uttam
U
Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
Ghosh
Animesh
A
Chakrabarty
Uday S
US
Mandal
Uttam
U
Bose
Anirbandeep
A
Das
Ayan
A
Ray
Kamala Kanta
KK
Pal
Tapan K
TK
D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D007194:India; D007202:Indicators and Reagents; D008297:Male; D008875:Middle Aged; D013056:Spectrophotometry, Ultraviolet; D013810:Therapeutic Equivalency; D055815:Young Adult; D047090:beta-Lactams / Q000008:administration & dosage / Q000493:pharmacokinetics*
D000900:Anti-Bacterial Agents; D007202:Indicators and Reagents; D047090:beta-Lactams; C107057:fropenem