The effect of food on the pharmacokinetic properties and bioequivalence of two formulations of XXXX in healthy Chinese male subjects.

@entity407 @entity1 @entity2299 @entity61994 @entity2452
UNASSIGNED: 1.   @entity2452 is an effective treatment for primary @entity407 and @entity2299 . The aim of the present study was to investigate the effect of food on the pharmacokinetic properties and bioequivalence of the original, branded, formulation of @entity61994 and a new generic formulation in healthy Chinese male subjects under fasting and fed conditions. 2.   Under fasting and fed conditions, 90% CIs of the geometric mean of generic/branded AUC0-48   h ratios were 92.2-102.4%, 93.1-104.5%, the ratios of ln(AUC0-   ) were 92.6-103.7%, 93.2-103.5%, and ln(Cmax) ratios were 90.7-110.3%, 84.7-100.8%, respectively. The generic and branded formulations were bioequivalent in terms of rate and extent of absorption under both the conditions. The average values of AUC0-48   h, AUC0-    and Cmax decreased noticeably following a high-fat breakfast. Values for AUC0-48   h were 87.69% and 83.7%, values for AUC0-    were 87.5% and 84.6%, and values for Cmax were 45.0% and 50.4% in subjects given the generic and branded preparations, respectively. The absorption of @entity61994 tablets was delayed following a high-fat meal, with Tmax increasing by up to 2.43-fold. 3.   Both formulations were generally well tolerated, with no serious adverse reactions reported. The newly developed generic formulation may provide a reliable alternative to the branded tablets for @entity1 with primary @entity407 or @entity2299 .
