生物学的同等性とバイオアベイラビリティのジャーナル

概要

Bioequivalence Study of Two Minocycline Capsule Formulations in Healthy Subjects

Effi 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 the two study periods (separated by a washout of one week) single dose of test or reference drug was administered. Blood samples were taken up to 60 h post dose, the plasma was separated and the concentration of minocycline were determined by HPLC-UV method. In this study, the mean (SD) AUC t, AUC inf , C max , and t ½ of minocycline from the test drug were 17272.46 (3316.80) ng.h.mL -1 , 19438.68 (3862.36) ng.h.mL -1 , 938.75 (192.92) ng/mL, and 19.46 (4.90) h, respectively, with the median (range) t max of minocycline from the test drug was 2.00 (0.67 – 3.00) h. The mean (SD) AUC t , AUC inf , C max , and t ½ of minocycline from the reference drug were 16999.33 (3103.27) ng.h.mL -1 , 19078.66 (3401.97) ng.h.mL -1 , 944.19 (188.56) ng/mL, and 18.90 (4.84) h, respectively, with the median (range) t max of minocycline from the reference drug was 2.00 (1.00 – 3.00) h. The geometric mean ratios (90% C.I.) of the test drug/reference drug for minocycline were 101.36% (97.85 – 105.00%) for AUC t, 101.53% (98.31 – 104.85%) for AUC inf , and 99.22% (95.92 – 102.63%) for C max , respectively. Based on this study, it can be concluded that the two minocycline capsules (test and drug reference drug) were bioequivalent in term of the rate and extent of absorption.