Journal of Bioequivalence & Bioavailability

Deniati SH

Publications

• Research Article
  Bioequivalence Study with Two Naproxen Sodium Tablet Formulations in Healthy Subjects
  Author(s): Setiawati E, Deniati SH, Yunaidi DA, Handayani LR, Harinanto G, Santoso ID, Purnomo Sari A and Rimainar ASetiawati E, Deniati SH, Yunaidi DA, Handayani LR, Harinanto G, Santoso ID, Purnomo Sari A and Rimainar A
  
  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 (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 ). 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.. View More»
  DOI: 10.4172/jbb.1000005

  Abstract PDF