Study on bioequivalence evaluation of dexamethasone acetate tablets in Chinese healthy volunteers
10.12092/j.issn.1009-2501.2023.12.006
- Author:
Lei XIAO
1
;
Xiaoqing HUANG
1
;
Wen ZHANG
2
;
Yang CAO
2
;
Shunwang HUANG
2
;
Yuanyuan XU
3
;
Jing XIE
3
;
Huan ZHOU
3
Author Information
1. Department of Pharmacy, The First Affiliated Hospital of Anhui Medical University
2. Hefei Innovative Medical Technology Co., Ltd.
3. National Drug Clinical Trial Institution The First Affiliated Hospital of Bengbu Medical College
- Publication Type:Journal Article
- Keywords:
bioequivalence;
dexamethasone acetate tablets;
pharmacokinetics
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2023;28(12):1365-1371
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To assess the bioequivalence of oral dexamethasone acetate tablets between the test and reference formulations in healthy adult Chinese subjects on an empty stomach and after meals. METHODS: A randomized, open, single-dose, two-cycle double crossover bioequivalence study was followed. Twenty-four healthy subjects were included in the fasting group, and 32 healthy subjects were included in the postprandial group, taking 2 tablets (0.75 mg/tablet) of the test formulation (T) or 3 tablets (0.50 mg/tablet) of the reference formulation (R) per cycle for two cycles. The concentrations of dexamethasone acetate in human plasma were determined using liquid chromatography-mass spectrometry, and the pharmacokinetic parameters were calculated according to the non-atrial model using WinNonlin 8.0 software.The bioequivalence of both the test formulation and the reference formulation was evaluated. RESULTS: The pharmacokinetic parameters after oral administration of dexamethasone acetate tablets in a fasted state in subjects with the reference formulation are as follows: Tmax 1.13 (0.50, 4.00) and 1.00 (0.50, 5.00) h, AUC0-t (72.25±21.55) and (69.23±17.76) ng · mL
