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Free Content Bioequivalence of fixed-dose combination Myrin®-P Forte and reference drugs in loose combination

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BACKGROUND: Myrin®-P Forte is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg), isoniazid (INH, 75 mg), ethambutol (EMB) hydrochloride (275 mg) and pyrazinamide (PZA, 400 mg) developed for the treatment of tuberculosis (TB).

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.
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Keywords: anti-tuberculosis; ethambutol; isoniazid; pyrazinamide; rifampicin

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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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on lung health world-wide.

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