Determination of Interchangeability of Different Brands of Diclofenac Sodium Sustained Release Tablets in Healthy Subjects Using Pharmacokinetic End Points
Tanveer A. Wani,
P. L. Sharma,
J. K. Paliwal.
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).
Keywords: Diclofenac Sodium, Sustained Release, Cmax, Tmax, AUC0-t, AUC0-inf, Bioequivalence
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