PMID: 11332875May 3, 2001Paper

Bioequivalence of two rimantadine tablet formulations in healthy male volunteers after single dose administration

International Journal of Clinical Pharmacology and Therapeutics
J ChládekA Franc

Abstract

The bioequivalence of two rimantadine tablet formulations was determined. The study was designed as a randomized, two-period, two-sequence, crossover study. Twenty-four healthy male volunteers received a single 100 mg dose of rimantadine hydrochloride as test (Rimantadin Lachema 100 tbl. obd., produced by Lachema, a.s., Brno, Czech Republic) and reference formulations (Elumadine 100 tbl. obd., produced by Forest Pharmaceuticals, St. Louis, USA). The two administrations were separated by 14 days and were performed in the fasting state. Blood samples were obtained at 15 time points during the interval 0-120 h after administration. Rimantadine plasma concentrations were determined by gas chromatography with electron-capture detection. The geometric mean concentration-time profiles of rimantadine after administration of the two formulations were superimposable. The following pharmacokinetic parameters refer to the geometric mean [exp(mean +/- SD)] values for the test and reference formulations, respectively: Cmax (ng/ml) 70.5 (60.0-82.7) vs. 70.0 (59.9 to 81.7), AUC(0-infinity) (ng x h/ml) 2872 (2224 to 3707) vs. 2849 (2195-3699), AUC(0-120 h) 2744 (2184-3448) vs. 2712 (2138-3441), t(1/2) (h) 25.8 (20.1-33.0) vs. 25.7 (20.6 to 32.1...Continue Reading

Citations

Dec 31, 2003·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Igor A Buryakov
Jul 14, 2010·The American Journal of Chinese Medicine·Shulan SuYuping Tang
Aug 14, 2008·CNS Drugs·Christopher PittengerGerard Sanacora
Jun 19, 2015·Basic & Clinical Pharmacology & Toxicology·Isabel MorenoFrancisco Abad-Santos

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