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NCT04080609 Clinical Trial

DDI Study Between Dorzagliatin and Rifampicin

Drug Interaction Clinical Trial

Official title:
A Single Dose, Open Label, Drug-drug Interaction Study to Investigate the Pharmacokinetics and Safety of Dorzagliation Administered Alone or in Combination With Rifampicin in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04080609
Other study ID # HMM0108
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 27, 2018
Est. completion date April 17, 2018

Study information
Verified date September 2019
Source Hua Medicine Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on the pharmacokinetics of Dorzagliatin.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date April 17, 2018
Est. primary completion date April 17, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Body weight = 50 kg (male) or = 45 kg (female)

- BMI within 19~26 kg/m2

Exclusion Criteria:

- History or disease status that may impact the ADME of the study

- Use of any drugs, OTCs, or hebal within 4 weeks of screening

- Drug abuse

- Blood donation

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dorzagliatin
GKA currently under clinical development

Locations
Country Name City State
China Central Hospital of Xuhui District Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Hua Medicine Limited

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax Peak plasma concentration up to 96 hours
Primary AUClast Area under the plasma concentration curve up to 96 hours
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