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Drug Interaction Study Between Dorzagliatin and Empagliflozin

NCT03790787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-03-24

No results posted yet for this study

Summary

This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and empagliflozin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will be studied.

Conditions

  • Patients

Interventions

DRUG

Empagliflozin

Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration

DRUG

Dorzagliatin

Glucokinase activator currently under development

Sponsors & Collaborators

  • Hua Medicine Limited

    lead INDUSTRY

Principal Investigators

  • Gregory J Tracey, MD · Frontage Clinical Services, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-18
Primary Completion
2020-03-15
Completion
2020-03-15
FDA Drug
Yes

Countries

  • United States

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 NCT03790787 on ClinicalTrials.gov