A Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

July 31, 2022

Study Completion Date

September 30, 2022

Conditions
Healthy Subject
Interventions
DRUG

HMPL-523

This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test \[T\]/Reference\[R\]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product \[i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.\], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).

Trial Locations (1)

Unknown

Shanghai Xuhui Central Hospital, Shanghai

All Listed Sponsors
lead

Hutchison Medipharma Limited

INDUSTRY