Bioequivalence and Pharmacokinetic Profiles of Generic and Branded Obeticholic Acid in Healthy Chinese Subjects Under Fasting and Fed Conditions - Wang, Meng-Na; Yu, Hai-Tao; Li, Ya-Qian; Zeng, Yun; Yang, Shuang; Yang, Guo-Ping; Pei, Qi; Huang, Jie (Drug design, development and therapy, 2021)
Keywords: Acids; Adolescent; Adult; Adverse events; Asians; Bile; Bioequivalence; Blood & organ donations; Chenodeoxycholic Acid - analogs & derivatives; Chenodeoxycholic Acid - blood; Chenodeoxycholic Acid - pharmacokinetics; Confidence intervals; Disease; Drug Compounding; Drug dosages; Drugs, Generic - analysis; Drugs, Generic - pharmacokinetics; Fasting; Fasting - blood; Female; food effect; Food intake; Food-Drug Interactions; Healthy Volunteers; High fat diet; Humans; Male; Meals; Metabolites; obeticholic acid; Original Research; Parameters; Pharmacokinetics; Pharmacology; Plasma; Therapeutic Equivalency; Variance analysis; Young Adult; China; United States--US; obeticholic acid; pharmacokinetics; food effect; bioequivalence