To evaluate the bioequivalence of a single oral dose of HRX0701 tablets and the reference formulations retagliptin phosphate tablets and metformin hydrochloride tablets in healthy subjects in the postprandial state; To evaluate the pharmacokinetic effects of a high-fat diet on retagliptin and metformin after a single oral administration of HRX0701 tablets in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
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.
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).
Xiangya Third Hospital
Changsha, Hunan, China
PK parameters Cmax, in the postprandial plasma of subjects in postprandial plasma
Time frame: day 1 to day 18
PK parameters AUC0-t in the postprandial plasma of subjects in postprandial plasma
Time frame: day 1 to day 18
PK parameters AUC0-∞ in the postprandial plasma of subjects in postprandial plasma
Time frame: day 1 to day 18
The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals reach peak time (Tmax)
Time frame: day 1 to day 18
The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals peak concentration (Cmax)
Time frame: day 1 to day 18
The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-t)
Time frame: day 1 to day 18
The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-∞)
Time frame: day 1 to day 18
Apparent distribution volume (Vz/F)
Time frame: day 1 to day 18
apparent clearance (CL/F)
Time frame: day 1 to day 18
terminal phase half-life (t1/2)
Time frame: day 1 to day 18
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retagliptin and metformin in plasma on fasting and after meals
Time frame: day 1 to day 18
The main metabolites of retagliptin acid PK parameters Cmax
Time frame: day 1 to day 18
The main metabolites of retagliptin acid AUC0-t
Time frame: day 1 to day 18
The main metabolites of retagliptin acid AUC0-∞
Time frame: day 1 to day 18
Adverse events
Time frame: day 1 to day 25