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Comparative pharmacokinetics between tenofovir disoproxil phosphate and tenofovir disoproxil fumarate in healthy subjects

Translational and Clinical Pharmacology 2021년 29권 1호 p.45 ~ 52
이상미, Kim Eun-Woo, Moon Seol-Ju, Jung Ji-Na, 이승환, 유경상,
소속 상세정보
이상미 ( Lee Sang-Mi ) - Seoul National University College of Medicine and Hospital Department of Clinical Pharmacology and Therapeutics
 ( Kim Eun-Woo ) - Seoul National University College of Medicine and Hospital Department of Clinical Pharmacology and Therapeutics
 ( Moon Seol-Ju ) - Chonbuk National University School of Medicine Department of Pharmacology
 ( Jung Ji-Na ) - Hanmi Pharmaceuticals Co. Ltd.
이승환 ( Lee Seung-Hwan ) - Seoul National University College of Medicine and Hospital Department of Clinical Pharmacology and Therapeutics
유경상 ( Yu Kyung-Sang ) - Seoul National University College of Medicine and Hospital Department of Clinical Pharmacology and Therapeutics

Abstract


Tenofovir is the representative treatment for human immunodeficiency virus and hepatitis B virus infection. This study was conducted to assess the pharmacokinetics (PKs) and safety characteristics after a single administration of tenofovir disoproxil phosphate compared to tenofovir disoproxil fumarate in healthy male subjects. An open-label, randomized, single administration, two-treatment, two-sequence crossover study was conducted in 37 healthy volunteers. Serial blood samples were collected up to 72 hours. Non-compartmental analysis was used to calculate the PK parameters. The 90% confidence intervals (90% CIs) of the geometric mean ratio (GMR) were calculated for comparing tenofovir disoproxil phosphate to tenofovir disoproxil fumarate. Safety assessments were performed including clinical laboratory tests, adverse events, etc. during the study. The GMR and 90% CIs were 1.0514 (0.9527?1.1603) for Cmax and 1.0375 (0.9516?1.1311) for AUClast, respectively, and both fell within the conventional bioequivalence range of 0.8?1.25. Both tenofovir salt forms were tolerable. This study demonstrated that tenofovir disoproxil phosphate (292 mg) was bioequivalent to tenofovir disoproxil fumarate (300 mg).

키워드

Tenofovir; Phosphate; Fumarate; Bioequivalence; Comparative Pharmacokinetics

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