We sincerely thank all the volunteers for participating in this clinical study. Furthermore, we sincerely thank Suzhou Guochen Biotek Co, Ltd. for their support in analyzing the samples.
机构署名:
本校为其他机构
摘要:
This study aimed to evaluate the bioequivalence between a generic roxatidine acetate hydrochloride (RAH) sustained-release capsule and brand-named formulation (ALTAT) under fasting and fed conditions. An open-label, single-center, randomized 2-period crossover study with a 5-day washout period was conducted. A single oral dose of 75-mg generic RAH sustained-release capsule (test drug) or a commercial capsule (reference drug) was given to healthy volunteers under fasting (n = 36) and fed conditions (n = 36). Blood samples were collected at basel...