drugset / Trial / NCT04859452

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

NCT04859452

Phase 1 Completed 56 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-05-26
Primary completion
2021-07-03
Completion
2021-07-09

Drugs

EvaluationDrugModalityDoseRoute
Subject DBPR108 Small molecule 100 mg Oral
Subject Glyburide Small molecule Oral
Subject Metformin Small molecule Oral
Subject Simvastatin Small molecule Oral
Subject Valsartan Small molecule Oral

Indications

No indication recorded.