Pharmacokinetics and Comparative Bioavailability Study of Two Clarithromycin Suspensions Following Administration of a Single Oral Dose to Healthy Volunteers

Parvin Zakeri-Milani; Hadi Valizadeh; Saeed Ghanbarzadeh; Mahboob Nemati

doi:10.1055/s-0031-1296419

Arzneimittelforschung, Table of Contents

Arzneimittelforschung 2009; 59(8): 429-432
DOI: 10.1055/s-0031-1296419

Antibiotics · Antimycotics · Antiparasitics · Antiviral Drugs · Chemotherapeutics · Cytostatics

Editio Cantor Verlag Aulendorf (Germany)

Pharmacokinetics and Comparative Bioavailability Study of Two Clarithromycin Suspensions Following Administration of a Single Oral Dose to Healthy Volunteers

Parvin Zakeri-Milani

¹Department of Pharmaceutics, Tabriz University of Medical Sciences, Tabriz, (Iran)

²Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz, (Iran)

,

Hadi Valizadeh

¹Department of Pharmaceutics, Tabriz University of Medical Sciences, Tabriz, (Iran)

³Research Center for Pharmaceutical Nanotechnology, Tabriz University of Medical Sciences, Tabriz, (Iran)

,

Saeed Ghanbarzadeh

¹Department of Pharmaceutics, Tabriz University of Medical Sciences, Tabriz, (Iran)

,

Mahboob Nemati

¹Department of Pharmaceutics, Tabriz University of Medical Sciences, Tabriz, (Iran)

⁴Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, (Iran)

› Author Affiliations

Abstract

The aim of the present study was to compare the pharmacokinetics and bioavailability of two commercial brands of clarithromycin (CAS 81103-11-9) suspensions in healthy male Iranian volunteers. In an open label, single-dose, randomized study with a crossover design an equivalent 500-mg clarithromycin suspension was given orally to each of 24 subjects as a single dose on two treatment days. The treatment periods were separated by a one-week washout period. Blood samples were drawn at different time points and the separated plasma was kept frozen at −20 °C for subsequent analysis. The plasma concentrations of the drug were analyzed by a rapid and sensitive HPLC method with UV detection.

Mean maximum serum concentrations of 2 256.5 ± 590.1 ng/mL and 2 840.2 ± 717.5 ng/mL were obtained for the test and reference formulation, respectively. The AUC_0–infinity of clarithromycin was on average 45 008.7 ± 10 989.9 ng · h/mL for the test and 45 221.3 ± 2155.7 ng h/mL for the reference formulation. The calculated 90% confidence intervals for the ratio of C_max (81.98–94.26%), (91.6–109.15%) and (93.08–110.85%) values for the test and reference products were all within the 85–120% interval proposed by the FDA and EMEA. Therefore the clarithromycin suspension of the test and reference formulations are bioequivalent in terms of rate and extent of absorption.

Key words

CAS 81103-11-9 - Clarithromycin, bioavailability, bioequivalence, pharmacokinetics - Klarexir® - Macrolide antibiotic

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References

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