Bioequivalence study of pramipexole hydrochloride tablets in Chinese healthy subjects

Author: Xiaoru WANG ¹ ; Xueyuan ZHANG ¹ ; Xiaoyan WANG ¹ ; Hanyu YANG ¹ ; Xiaoru WANG ² ; Xueyuan ZHANG ² ; Xiaoyan WANG ² ; Hanyu YANG ²
Author Information

1. CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.
2. State Key Laboratory of New Pharmaceutical Preparations and Excipients
Publication Type:Journal Article
Keywords: Bioequivalence; Pharmacokinetics; Pramipexole
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(2):190-195
CountryChina
Language:Chinese
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