Bioequivalence study of pramipexole hydrochloride tablets in Chinese healthy subjects / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
;
(12): 190-195, 2021.
Artículo
en Chino
| WPRIM
| ID: wpr-1015084
ABSTRACT
AIM:
To assess the bioequivalence of pramipexole hydrochloride tablets with reference(Sifrol).METHODS:
A randomized, open-label, 2-period crossover study was conducted in 48 healthy Chinese volunteers under fasted or fed conditions (24 volunteers for each condition). In each session, the subjects received a single oral dose of 0.25 mg test (T) or reference (R) formulation. Pramipexole concentrations in plasma were determined by a validated HPLC-MS/MS. Pharmacokinetic parameters were calculated using a non-compartmental model through Phoenix WinNonlin version 6.4. Other statistic analysis were analyzed by using software of SAS 9.3.RESULTS:
The pharmacokinetic parameters of test drug and reference drug under fasted condition(n=20) were C
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Idioma:
Chino
Revista:
Chinese Journal of Clinical Pharmacology and Therapeutics
Año:
2021
Tipo del documento:
Artículo
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