Bioequivalence of apixaban tablets in healthy Chinese subjects / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
;
(12): 306-311, 2020.
Artículo
en Chino
| WPRIM
| ID: wpr-855881
ABSTRACT
AIM:
To evaluate the bioequivalence of the two preparations of apixaban tablets administered once orally under fasting and fed conditions.METHODS:
The study was designed as randomized, open, self-crossover, and twenty four healthy volunteers were recruited respectively in fasting and fed conditions. Subjects were assigned to receive a single oral of the test or reference formulation per period at a dose of 2.5 mg. The plasma apixaban concentration was analyzed by LC-MS/MS. The major pharmacokinetic parameters were calculated by WinNonlin 6.4 and the bioequivalence was evaluated.RESULTS:
The main pharmacokinetic parameters of a single oral apixaban under fasting condition for T and R were as follows Cmax (80±14) and (87±21) ng/mL, AUC0-t (713±136) and (733±142) h•ng•mL-1, AUC0-∞ (722±143) and (741±142) h•ng•mL-1, tmax 2.5 h and 2.5 h, t1/2 (9±8) and (8±6) h. The relative bioavailability was 97.16% for AUC0-t, 97.20% for AUC0-∞. The main pharmacokinetic parameters of a single oral apixaban under fed condition for T and R were as follows Cmax (70±13), (72±13) ng/mL; AUC0-t (642±130), (690±135) h•ng•mL-1; AUC0-∞ (652±129), (704±138) h•ng•mL-1. tmax 2.5 h and 2.5 h, t1/2 (8±4) and (12±9) h. The relative bioavailability was 93.03% for AUC0-t, 92.62% for AUC0-∞.CONCLUSION:
The test preparation of apixaban tablets is bioequivalent to the reference preparation under both fasting and fed conditions.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Tipo de estudio:
Ensayo Clínico Controlado
Idioma:
Chino
Revista:
Chinese Journal of Clinical Pharmacology and Therapeutics
Año:
2020
Tipo del documento:
Artículo
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