NDLI: Bioequivalence study of 2 formulations of film-coated tablets containing a fixed dose combination of bisoprolol fumarate 5 mg and hydrochlorothiazide 6.25 mg in healthy subjects.

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Bioequivalence study of 2 formulations of film-coated tablets containing a fixed dose combination of bisoprolol fumarate 5 mg and hydrochlorothiazide 6.25 mg in healthy subjects.

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Bioequivalence study of 2 formulations of film-coated tablets containing a fixed dose combination of bisoprolol fumarate 5 mg and hydrochlorothiazide 6.25 mg in healthy subjects.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Tjandrawinata, R. R. Setiawati, E. Yunaidi, D. A. Santoso, I. D. Setiawati, A. Susanto, L. W.
Description	Country affiliation: Indonesia Author Affiliation: Tjandrawinata RR ( Dexa Laboratories of Biomolecular Sciences (DLBS), Cikarang, Indonesia.)
Abstract	BACKGROUND: The present study was conducted to compare the bioavailability of 2 formulations of fixed-dose combination of bisoprolol fumarate 5 mg and hydrochlorotiazide (HCT) 6.25 mg film-coated tablet (test and reference formulations). METHODS: This study was a randomized, single-blind, 2-period, 2-sequence cross-over study which included 18 healthy adult male and female subjects under fasting condition. The pharmacokinetic parameters, AUCt, AUCinf, Cmax, tmax, and t½ were determined based on the concentrations of bisoprolol (CAS 66722-44-9) and HCT (CAS 58-93-5), using ultra-performance liquid chromatography with tandem mass spectrometer detector (UPLC-MS/MS). In each of the 2 study periods (with a washout of 1 week) a single dose of test or reference product was administered. RESULTS: The geometric mean ratios (90% CI) of the test drug/reference drug for bisoprolol were 97.22% (93.75-100.83%) for AUCt(0-48), 97.20% (93.97-100.54%) for AUCinf, and 100.36% (93.83-107.34%) for Cmax; while those for HCT were 93.22% (84.72-102.57%), 93.39% (85.43-102.10%) and 99.39% (85.45-115.61%), for AUCt(0-24), AUCinf, and Cmax, respectively. The differences between the test and reference drug products for tmax values of bisoprolol as well as t½ values of both bisoprolol and hydrochlorothiazide were not statistically significant; yet, the difference was statistically significant for the tmax values of hydrochlorothiazide. There was no adverse event encountered during this bioequivalence test. MAJOR CONCLUSION: It was concluded that the 2 formulations of fixed dose combination of bisoprolol fumarate 5 mg and hydrochlorotiazide (HCT) 6.25 mg film-coated tablet (the test and reference products) were bioequivalent.
File Format	HTM / HTML
ISSN	21949379
Issue Number	5
Volume Number	63
e-ISSN	21949387
Journal	Drug Research
Language	English
Publisher	Thieme
Publisher Date	2013-05-01
Publisher Place	Germany
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Antihypertensive Agents Pharmacokinetics Bisoprolol Hydrochlorothiazide Adult Area Under Curve Administration & Dosage Chemistry, Pharmaceutical Cross-over Studies Drug Combinations Female Humans Male Single-blind Method Tablets Therapeutic Equivalency Journal Article Randomized Controlled Trial
Content Type	Text
Resource Type	Article
Subject	Medicine Drug Discovery

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