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Drug Interaction Study Between Dorzagliatin and Sitagliptin

NCT03790839 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-02-28

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 sitagliptin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and sitagliptin given alone and in combination will be studied.

Conditions

  • Patients

Interventions

DRUG

Sitagliptin

Sitagliptin (Januvia® 100 mg tablets for oral administration)

DRUG

Dorzagliatin

Glucokinase activator currently under development

Sponsors & Collaborators

  • Hua Medicine Limited

    lead INDUSTRY

Principal Investigators

  • Gregory 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
2019-01-31
Primary Completion
2019-08-30
Completion
2019-08-30
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 NCT03790839 on ClinicalTrials.gov