Open AccessBioequivalence and Pharmacokinetic Profiles of Generic and Branded Obeticholic Acid in Healthy Chinese Subjects Under Fasting and Fed Conditions
Author(s) -
Meng-Na Wang,
Haitao Yu,
Yaqian Li,
Yang Zeng,
Shuang Yang,
Guoping Yang,
Qi Pei,
Jie Huang
Publication year - 2021
Publication title -
drug design, development and therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.964
H-Index - 64
ISSN - 1177-8881
DOI - 10.2147/dddt.s289016
Subject(s) - bioequivalence , pharmacokinetics , crossover study , confidence interval , medicine , pharmacology , zoology , adverse effect , placebo , biology , alternative medicine , pathology
This study was conducted to evaluate the bioequivalence (BE) of a generic form of obeticholic acid (OCA) and Ocaliva TM under fasting and fed conditions and to determine the effects of food on the pharmacokinetic (PK) profiles of OCA in healthy Chinese subjects.