U.S., Jan. 10 -- ClinicalTrials.gov registry received information related to the study (NCT07331194) titled 'Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans' on Sept. 11, 2025.
Brief Summary: Two formulations containing the same active pharmaceutical ingredient are considered bioequivalent if their relative bioavailability (rate and extent of drug absorption) falls within acceptable predetermined limits after administration at the same molar dose. Formulations with bioequivalence are considered to act comparably in vivo, i.e., similar in terms of safety and efficacy.
This study aims to evaluate the pharmacokinetic (PK) profile and bioequivalence of the original and modified formulations of HMPL-523 acetate ...