Determination of Interchangeability of Different Brands of Diclofenac Sodium Sustained Release Tablets in Healthy Subjects Using Pharmacokinetic End Points

Title: Determination of Interchangeability of Different Brands of Diclofenac Sodium Sustained Release Tablets in Healthy Subjects Using Pharmacokinetic End Points

Volume: 6 Issue: 8

Author(s): Tanveer A. Wani, Abdus Samad, P. L. Sharma, Monika Tandon and J. K. Paliwal

Affiliation:

Keywords: Diclofenac Sodium, Sustained Release, Cmax, Tmax, AUC0-t, AUC0-inf, Bioequivalence

Abstract: This was an open label, balanced, randomized, three-treatment, three-sequence, three period, single-dose, crossover bioavailability study in which healthy adults (age18-45 years) were randomized to receive sustained release tablets of Voveran SR (Product R), Nac SR (Product A) and Reactin SR (Product B) each containing diclofenac sodium 100 mg with at least 3 days wash out between treatments. Eighteen healthy, adult, male, human subjects who met the inclusion and exclusion criteria as described in the protocol were enrolled in the study. Pharmacokinetic parameters like Tmax, Cmax, AUC 0-t, AUC 0-∞, AUC0-t/ AUC 0-∞, Kel, T1/2 & MRT were calculated for the Products A, B and R. Product A fared better than product B in some bioequivalence parameters. However, both the test products (Nac SR and Reactin SR) were not bioequivalent to product R (Voveran SR).

Cite this article as:

Wani A. Tanveer, Samad Abdus, Sharma L. P., Tandon Monika and Paliwal K. J., Determination of Interchangeability of Different Brands of Diclofenac Sodium Sustained Release Tablets in Healthy Subjects Using Pharmacokinetic End Points, Letters in Drug Design & Discovery 2009; 6 (8) . https://dx.doi.org/10.2174/157018009789353518