Bioequivalence Study with Two Naproxen
Sodium Tablet Formulations in Healthy Subjects |
| Setiawati E*, Deniati SH, Yunaidi DA, Handayani LR,
Harinanto G, Santoso ID, Purnomo Sari A, Rimainar A |
| PT Equilab International, Bioavailability and Bioequivalence Laboratory, Jakarta (Indonesia) |
| *Corresponding author: |
Dr Effi Setiawati, PT Equilab International, Jl. Utan Kayu 45,
Jakarta 13120 (Indonesia),
E-mail: effi@equilab-int.com |
|
| Received March 20, 2009; Accepted April 19, 2009; Published May 05, 2009 |
| Citation: Setiawati E, Deniati SH, Yunaidi DA, Handayani LR, Harinanto G, et al. (2009) Bioequivalence Study with Two
Naproxen Sodium Tablet Formulations in Healthy Subjects. J Bioequiv Availab 1: 028-033.
doi:10.4172/jbb.1000005 |
| Copyright: © 2009 Setiawati E, et al. This is an open-access article distributed under the terms of the Creative Commons
Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author
and source are credited. |
| Abstract |
The purpose of this study was to find out whether the bioavailability of a 550 mg naproxen sodium (CAS 22204-53-
1 ) tablet (Sunprox, test) produced by Sunward Pharmaceutical Sdn Bhd was equivalent to that produced by the
innovator. The pharmacokinetic parameters assessed in this study were area under the plasma concentration-time
curve from time zero to 72 hours (AUCt), area under the plasma concentration-time curve from time zero to infinity
(AUCinf), the peak plasma concentration of the drug (Cmax), time needed to achieve the peak plasma concentration
(tmax), and the elimination half life (t1/2).
This was a randomized, single blind, two-period, cross-over study which included 26 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 72 h post dose, the plasma was separated
and the concentration of naproxen were determined by HPLC-UV method.
In this study, the mean AUCt, AUCinf, Cmax, and t½ of naproxen from the test drug were 936.11 μg.h.mL-1, 977.03μg.h.mL-1, 76.55 μg/mL, and 15.11 h, respectively. The mean AUCt, AUCinf, Cmax, and t½ of naproxen from the reference
drug were 969.77 μg.h.mL-1, 1013.72 μg.h.mL-1, 75.92 μg/mL, and 15.11 h, respectively. The median tmax of he test
drug and reference drug were 3.0 h and 2.0 h, respectively. The geometric mean ratios (90% CI) of the test drug/
reference drug for naproxen were 96.46% (94.30 – 98.66%) for AUCt, 96.33% (94.03 – 98.69%) for AUCinf, and
100.37% (95.90 – 105.05%) for Cmax.
Based on this study, it can be concluded that the two naproxen sodium tablets (test and drug reference drug) were
bioequivalent in term of the rate and extent of absorption. |
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