This is a four-part, single-center, open-label, single-sequence crossover phase I clinical study to characterize the Drug-Drug Interaction (DDI) potential of DBPR108 at steady-state with Metformin hydrochloride, Glibenclamide, Valsartan, or Simvastatin in Healthy Subjects. This study also aims to evaluate the safety and tolerability of DBPR108 in the presence of Metformin hydrochloride, Glibenclamide, Valsartan, or Simvastatin.
DBPR108 is a potent dipeptidylpeptidase-4 inhibitor. This study will be run in four parts to characterize the Drug-Drug Interaction (DDI) potential of DBPR108 with the expected concomitant drugs (Metformin hydrochloride, Glibenclamide, Valsartan, Simvastatin) in Healthy Subjects. Each part of this study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 9), and a follow-up visit on Day 15. Approximately 14 subjects will be enrolled in each part of this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Drug: DBPR108, tablet, oral
Drug: Metformin hydrochloride, tablet, oral
Drug: Glibenclamide, tablet, oral
First Affiliated Hospital of Soochow University
Suzhou, China
The pharmacokinetic parameters of Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid and DBPR108
Peak Plasma Concentration (Cmax)
Time frame: Day 1 to Day 9
The pharmacokinetic parameters of Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid and DBPR108
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 to Day 9
The pharmacokinetic parameters
The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : Tmax
Time frame: Day 1 to Day 9
The pharmacokinetic parameters
The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : t1/2
Time frame: Day 1 to Day 9
The pharmacokinetic parameters
The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : Vz/F
Time frame: Day 1 to Day 9
The pharmacokinetic parameters
The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : CL/F
Time frame: Day 1 to Day 9
The number of volunteers with adverse events as a measure of safety and tolerability
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: Day 1 to Day 15
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Drug: Valsartan, capsule, oral
Drug: Simvastatin, tablet, oral