Poh SC
Malaysia
Research Article
Bioequivalence Study of Two Minocycline Capsule Formulations in
Healthy Subjects
Author(s): Effi Setiawati, Yunaidi DA, Handayani LR, Kurniawan YTI, Simanjuntak R, Santoso ID, Pramihadarini P and Poh SCEffi Setiawati, Yunaidi DA, Handayani LR, Kurniawan YTI, Simanjuntak R, Santoso ID, Pramihadarini P and Poh SC
The purpose of this study was to find out whether the bioavailability of 100 mg minocycline capsule manufactured by Y.S.P. Industries (M) Sdn. Bhd. was equivalent to that produced by Apotex Canada (Apo-Minocycline ® 100 mg). The pharmacokinetic parameters assessed in this study were area under the plasma concentration-time curve from time zero to the last observed quantifiable concentration (AUC t ), area under the plasma concentration-time curve from time zero to infinity (AUC inf ), the peak plasma concentration of the drug (C max ), time needed to achieve the peak plasma concentration (t max ), and the elimination half life (t 1/2 ). These parameters were determined on plasma concentrations of minocycline. This was a randomized, single blind, two-period, two-sequence crossover study which included 20 healthy adult male and female subjects under fasting conditions. In each of th.. View More»
DOI:
10.4172/jbb.1000071