Study of the Bioequivalence and Food Effects of HRX0701 Tablets in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

July 5, 2022

Primary Completion Date

August 8, 2022

Study Completion Date

August 8, 2022

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets

"High-specification group: subject preparation: HRX0701 (50 mg/1000 mg) 1 tablet (to be taken after a meal); Reference preparation: 1 tablet of retagliptin phosphate (50 mg), 2 tablets of metformin hydrochloride (Glucophage®) (500 mg), taken twice after meals.~Low Specification Group:~Preparation: HRX0701 (50 mg/850 mg) 1 tablet (taken after a meal); Reference: 1 tablet of retagliptin phosphate (50 mg), 1 tablet of metformin hydrochloride (Glucophage®) (850 mg), taken twice after meals."

DRUG

hrx0701 tablets

"High specification group HRX0701 (FDC) tablets (50 mg / 1000 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach).~Low-spec group HRX0701 (FDC) tablets (50 mg / 850 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach)."

Trial Locations (1)

410013

Xiangya Third Hospital, Changsha

All Listed Sponsors
lead

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY