NDLI: Bioequivalence study of two risedronate sodium film-coated tablet formulations in healthy volunteers.

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Bioequivalence study of two risedronate sodium film-coated tablet formulations in healthy volunteers.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Simanjuntak, R. Setiawati, E. Yunaidi, D. A. Handayani, L. R. Setiawati, A. Utami, B. S. Rosa, T. A. Sholeh, A. B.
Description	Country affiliation: Indonesia Author Affiliation: Simanjuntak R ( Equilab International, Bioavailability-Bioequivalence, Jakarta, Indonesia.); Setiawati E ( Equilab International, Bioavailability-Bioequivalence, Jakarta, Indonesia.); Yunaidi DA ( Equilab International, Bioavailability-Bioequivalence, Jakarta, Indonesia.); Handayani LR ( Equilab International, Bioavailability-Bioequivalence, Jakarta, Indonesia.); Setiawati A ( Pharmacology and Therapeutics, University of Indonesia, Jakarta, Indonesia.); Utami BS ( PT Phapros Tbk., Manufacturing, Semarang, Indonesia.); Rosa TA ( PT Phapros Tbk., Manufacturing, Semarang, Indonesia.); Sholeh AB ( PT Phapros Tbk., Manufacturing, Semarang, Indonesia.)
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.
File Format	HTM / HTML
ISSN	21949379
Issue Number	3
Volume Number	64
e-ISSN	21949387
Journal	Drug Research
Language	English
Publisher	Thieme
Publisher Date	2014-03-01
Publisher Place	Germany
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Bone Density Conservation Agents Pharmacokinetics Chromatography, High Pressure Liquid Methods Etidronic Acid Analogs & Derivatives Adolescent Adult Biological Availability Administration & Dosage Chemistry, Pharmaceutical Cross-over Studies Female Humans Hydrogen-ion Concentration Male Middle Aged Risedronate Sodium Single-blind Method Solubility Tablets Therapeutic Equivalency Young Adult Comparative Study Journal Article Randomized Controlled Trial
Content Type	Text
Resource Type	Article
Subject	Medicine Drug Discovery

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