Bioequivalence of fixed-dose combination Myrin®-P Forte and reference drugs in loose combination
SETTING: This study was conducted at a single centre—the Pfizer Clinical Research Unit in Singapore.
OBJECTIVE: To demonstrate the bioequivalence of each drug component of the Myrin-P Forte FDC and the individual product in loose combination.
DESIGN: In a randomized, open-label, single-dose, two-way, crossover study, subjects received single doses of Myrin-P Forte or four individual products under fasting conditions in a crossover fashion with at least 7 days washout between doses. The primary measures for comparison were peak plasma concentration (Cmax) and the area under plasma concentration–time curve (AUC).
RESULTS: Of 36 subjects enrolled, 35 completed the study. The adjusted geometric mean ratios and 90% confidence intervals for Cmax and AUC values were completely contained within bioequivalence limits (80%, 125%) for all four drugs in both formulations. Both treatments were generally well tolerated in the study.
CONCLUSION: The Myrin-P Forte FDC tablet formulation is bioequivalent to the four single-drug references for RMP, INH, EMB hydrochloride and PZA at equivalent doses.
Document Type: Research Article
Affiliations: 1: Pfizer Inc, Groton, Connecticut, USA 2: Pfizer Inc, New York, New York, USA 3: Pfizer Ltd, Karachi, Pakistan
Publication date: December 1, 2013
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