Drug Res (Stuttg) 2014; 64(3): 136-140
DOI: 10.1055/s-0033-1354365
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Bioequivalence Study of Two Risedronate Sodium Film-Coated Tablet Formulations in Healthy Volunteers

R. Simanjuntak1, E. Setiawati1, D. A. Yunaidi1, L. R. Handayani1, A. Setiawati2, B. S. Utami3, T. A. Rosa3, A. B. Sholeh3
  • 1Equilab International, Bioavailability-Bioequivalence, Jakarta, Indonesia
  • 2Pharmacology and Therapeutics, University of Indonesia, Jakarta, Indonesia
  • 3PT Phapros Tbk., Manufacturing, Semarang, Indonesia
Further Information

Publication History

received 14 June 2013

accepted 06 August 2013

Publication Date:
03 September 2013 (eFirst)

Abstract

The present study was performed to compare the bioavailability of 2 risedronate sodium 35 mg film-coated tablet formulations (test formulation and reference formulation). Prior to the present study, in vitro comparative dissolution test has been conducted for test and reference formulations. Dissolution profiles shown that more than 85% of the drug is dissolved within 15 min at pH 1.2, pH 4.5, and pH 6.8.

This study was a randomized, single-blind, 2-period, 2-sequence cross-over study which included 48 evaluable healthy adult male and female subjects under fasting condition. In each of the 2 study periods (separated by a washout of 3 weeks) a single dose of test or reference drug was administered. The pharmacokinetic parameters assessed in this study were cumulative urinary excretion from drug administration to 72 h (Ae72h) and maximum urine excretion rate (dAe/dtmax). These parameters were determined from urine concentrations of risedronate and urine volume. Urinary concentrations of the drug were determined by high performance liquid chromatographic method with UV detector.

The geometric mean ratios (90% CI) of the test drug/reference drug for risedronate were 106.60% (92.34–123.07%) for Ae72h and 104.75% (88.86–123.47%) for dA/dtmax. The geometric mean ratios calculated for Ae72h and dA/dtmax of risedronate were within the bioequivalence range (80.00–125.00% for Ae72h and dA/dtmax). It was concluded that the 2 risedronate sodium film-coated tablets (test and reference drugs) were bioequivalent.