 
        
						Bo  Yang
	
					    												
China						                            
                            
						
 Research Article
												Pharmacokinetics and Bioequivalence Evaluation of Two Voriconazole
tablets: an Open-Label, Single-Dose, Randomized, Two-Way Crossover
Study in Healthy Chinese Male Volunteers 						
Author(s): Xuewen  Qiu, Rongfeng  Xiang, Qing  Dai, Bo  Yang, Lirong  Xiong, Yangjing  Ou, Min  Tang and Yongchuan  ChenXuewen  Qiu, Rongfeng  Xiang, Qing  Dai, Bo  Yang, Lirong  Xiong, Yangjing  Ou, Min  Tang and Yongchuan  Chen             
						
												
				 The aim of this study was to assess and compare the pharmacokinetic properties, bioavailability, and bioequivalence of a newly developed tablet of voriconazole with those of an established branded formulation in healthy Chinese adult male volunteers.
An open-label, single-dose, randomized, 2-way crossover study was conducted in fasted healthy Chinese male volunteers. Eligible participants were randomly assigned in a 1:1 ratio to receive one tablet (200 mg) of the test or reference formulations, followed by a 1-week washout period and administration of the alternate formulations. Plasma samples were collected over 36 hours and analyzed by HPLC. The Voriconazole plasma concentration–time curves were used to obtain pharmacokinetic parameters including AUC0–t, AUC0–∞, Cmax and Tmax. The criteria for bioequivalence were 90% CIs of 80% to 125% for AUC and 70%.. View More»
				  
												DOI:
												 10.4172/jbb.10000110