DDI Study Between Dorzagliatin and Rifampicin

NCT ID: NCT04080609

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-27

Study Completion Date

2018-04-17

Brief Summary

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

Detailed Description

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Conditions

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Drug Interaction

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequential arm

Dorzagliatin was administered single dose; after wash-out, rifampicin was dosed continuously for 9 days, with Dorzagliatin dosed simultaneously on day 8.

Group Type EXPERIMENTAL

Dorzagliatin

Intervention Type DRUG

GKA currently under clinical development

Interventions

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Dorzagliatin

GKA currently under clinical development

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hua Medicine Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Central Hospital of Xuhui District

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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HMM0108

Identifier Type: -

Identifier Source: org_study_id

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