Bioequivalence of clarithromycin tablet formulations assessed in Korean males

Citation
Yg. Kim et al., Bioequivalence of clarithromycin tablet formulations assessed in Korean males, INT J CL PH, 39(8), 2001, pp. 356-361
Citations number
12
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Pharmacology & Toxicology
Journal title
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
ISSN journal
0946-1965 → ACNP
Volume
39
Issue
8
Year of publication
2001
Pages
356 - 361
Database
ISI
SICI code
0946-1965(200108)39:8<356:BOCTFA>2.0.ZU;2-8
Abstract
Aim: Determination of the bioequivalence of 2 clarithromycin tablet formula tions manufactured in Korea. Patients and methods: Twenty-four healthy male Korean volunteers received each of the 2 clarithromycin formulations at a dose of 250 mg in a 2 x 2 crossover study. There was a one-week washout per iod between doses. Plasma concentrations of clarithromycin were monitored b y high-performance liquid chromatography over a period of 12 hours at, ter administration. AUC(inf) (the area under the plasma concentration-time curv e from time zero to time infinity) was calculated using the linear-log trap ezoidal method. C-max (maximum plasma drug concentration) and T-max (time t o reach C-max) were compiled from the plasma concentration-time data. Analy sis of I variance was carried out using logarithmically transformed AUC(inf ) and C-max and untransformed T-max. Results: The point estimates and 90% c onfidence intervals for AUC(inf) (parametric) and C-max (parametric) were 0 .971 (0.886 similar to 1.063) and 0.982 (0.868 similar to 1.107), respectiv ely, satisfying the bioequivalence criteria of the European Committee for P roprietary Medicinal Products and the US Food and Drug Administration guide lines. The corresponding value of Tma, was 0.000 (-0.250 similar to 0.250). Conclusion: These results indicate that the 2 medications of clarithromyci n are bioequivalent and, thus, may be prescribed interchangeably.