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First received: September 11, 2025

Clinical Trial: Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Healthy

Study Type: INTERVENTIONAL


Official Title: A Single-Center, Open-Label, Randomized, Crossover Phase I Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of Two Different Formulations of HMPL-523 Acetate Tablets in Chinese Healt

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…

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