Average bioequivalence of clarithromycin immediate released tablet formulations in healthy male volunteers

Autor:	Sanglar Polnok, W. Chaiyaput, Sakchai Wittaya-areekul, Sareekan K, Manupat Lohitnavy, Ornrat Lohitnavy
Rok vydání:	2003
Předmět:	Adult Male Cmax Pharmaceutical Science Biological Availability Pharmacology Bioequivalence Dosage form Pharmacokinetics Clarithromycin Drug Discovery Medicine Humans Chromatography High Pressure Liquid Antibacterial agent Chromatography Cross-Over Studies business.industry Organic Chemistry Area under the curve Crossover study Bioavailability Anti-Bacterial Agents Solubility Therapeutic Equivalency Area Under Curve business Half-Life Tablets
Zdroj:	Drug development and industrial pharmacy. 29(6)
ISSN:	0363-9045
Popis:	The objective of this study was to assess average bioequivalence of two immediate released tablet formulations of 500-mg clarithromycin tablets in 24 healthy Thai male volunteers. In a randomized, single dose, fasting state, two-period, crossover study design with a 1-week washout period, each subject received a 500-mg clarithromycin tablet. Plasma samples were collected over a 24-hour period after oral administration and were analyzed by using a validated method using high performance liquid chromatography with electrochemical detection. Pharmacokinetic parameters were determined by using noncompartmental analysis. The time to reach the maximal concentration (tmax, h), the peak concentration (Cmax, ng/mL), and the area under the curve (AUC0-infinity, ng x h/mL) of the Reference and Test formulations were 2.0 +/- 0.8 vs. 2.2 +/- 0.9, 2793 +/- 1338 vs. 2642 +/- 1344, and 17912 +/- 7360 vs. 17660 +/- 7992, respectively. Relative bioavailability was 0.99. The 90% confidence interval of Cmax and AUC0-infinity were 82.6-112.1% and 84.7-112.0%. Bioequivalence between the Test and Reference formulation can be concluded.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c12b9d3b6dab594fc1418a49ee9419ac https://pubmed.ncbi.nlm.nih.gov/12889783 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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