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

NCT04859452 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-07-20

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04859452 on ClinicalTrials.gov