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

NCT07331194 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-02-12

No results posted yet for this study

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 tablets in healthy participants to bridge the safety and efficacy of the modified formulation of HMPL 523 acetate tablets in humans.

Conditions

  • Healthy

Interventions

DRUG

HMPL-523 Acetate Tablets (Test Formulation)

The trial participants were administered the drug on the first day of each cycle. dose 300mg

DRUG

HMPL-523 Acetate Tablets (Reference Formulation)

The trial participants were administered the drug on the first day of each cycle. dose 300mg

Sponsors & Collaborators

  • Hutchmed

    lead INDUSTRY

Principal Investigators

  • Bin Yang · Hutchmed

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2025-11-28
Completion
2026-02-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07331194 on ClinicalTrials.gov