Arzneimittelforschung 2008; 58(7): 342-347
DOI: 10.1055/s-0031-1296517
Analgesics · Anti-inflammatories · Antiphlogistics · Antirheumatic Drugs
Editio Cantor Verlag Aulendorf (Germany)

Bioequivalence Study of Two Formulations Containing 400 mg Dexibuprofen in Healthy Indian Subjects

Uttam Mandai
1  Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India
,
Ayan Das
1  Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India
,
Sangita Agarwal
1  Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India
,
Uday Chakraborty
1  Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India
,
Utpal Nandi
1  Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India
,
Tapas Kumar Chattaraj
2  Nilratan Sarkar Medical College and Hospital, Kolkata, India
,
Tapan Kumar Pal
1  Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India
› Author Affiliations
Further Information

Publication History

Publication Date:
15 December 2011 (online)

Abstract

Objective:

This study presents the results of two-period, two-treatment crossover investigations on 24 healthy Indian male subjects to assess the bioequivalence of two oral formulations containing 400 mg of dexibuprofen (CAS 51146–56–6). An attempt was also made to study the pharmacokinetics of dexibuprofen in the local population of Indian origin.

Method:

Both of the formulations were administered orally as a single dose separated by a one-week washout period. The concentration of dexibuprofen in plasma was determined by a validated HPLC method with UV detection using carbamazepine as internal standard. 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–∞), peak plasma concentration (Cmax), and time to reach peak plasma concentration (tmax).

Results:

The results of this investigation indicated that there were no statistically significant differences between the logarithmically transformed AUC0–∞ and Cmax values of the two preparations. The 90% confidence interval for the ratio of the logarithmically transformed AUC0–t, AUC0–∞ and Cmax were within the bioequivalence limit of 0.8–1.25 and the relative bioavailability of the test formulation was 99.04% of that of reference formulation.

Conclusion:

Thus, these findings clearly indicate that the two formulations are bioequivalent in terms of rate and extent of drug absorption. Both preparations were well tolerated with no adverse reactions observed throughout the study.