DDI Study Between Dorzagliatin and Rifampicin

September 4, 2019 updated by: Hua Medicine Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201203
        • Central Hospital of Xuhui District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequential arm
Dorzagliatin was administered single dose; after wash-out, rifampicin was dosed continuously for 9 days, with Dorzagliatin dosed simultaneously on day 8.
Drug: Dorzagliatin
GKA currently under clinical development

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: up to 96 hours
Peak plasma concentration
up to 96 hours
AUClast
Time Frame: up to 96 hours
Area under the plasma concentration curve
up to 96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Medicine Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2018

Primary Completion (Actual)

April 17, 2018

Study Completion (Actual)

April 17, 2018

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 4, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • HMM0108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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