Study S003347

A Randomized, Open-label, Multiple-dose Phase I Clinical Study to Evaluate the Effect of a High-fat Meal and Different Dosing Conditions on the Pharmacokinetics of BGM0504 Tablets in Healthy Chinese Participants.

ClinicalTrials.gov record

Registration

Registration: NCT07566572
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 144
Start: 2026-03-26
Primary completion: 2026-08-31
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Conditions: Chinese Healthy Volunteers
Interventions: DRUG:BGM0504 tablets
Results posted: FALSE

Registered primary outcomes

Pharmacokinetic (PK) endpoint： AUC0-tau,ss [4 weeks]
PK endpoint：Cmax,ss [4 weeks]
PK endpoint：t1/2,ss [4 weeks]

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