NCT04859452

A Study to Evaluate the DDI of DBPR108 With Metformin,Glibenclamide,Valsartan, or Simvastatin in Healthy Subjects

A Four-part, Single-center, Open-label, Phase I Clinical Study to Evaluate the Drug-Drug Pharmacokinetic Interaction Between DBPR108 at Steady-state and Metformin Hydrochloride/Glibenclamide/Valsartan/ Simvastatin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	DBPR108 tablets	Drug: DBPR108, tablet, oral
DRUG	Metformin hydrochloride tablets	Drug: Metformin hydrochloride, tablet, oral
DRUG	Glibenclamide tablets	Drug: Glibenclamide, tablet, oral
DRUG	Valsartan Capsules	Drug: Valsartan, capsule, oral
DRUG	Simvastatin tablets	Drug: Simvastatin, tablet, oral

Timeline

• Start date: 2021-05-26
• Primary completion: 2021-07-03
• Completion: 2021-07-09
• First posted: 2021-04-26
• Last updated: 2021-07-20

Locations

1 site across 1 country: China