DDI Study Between Dorzagliatin and Rifampicin

Phase 1

Completed

• Conditions: Drug Interaction
• Interventions: Drug: Dorzagliatin

• Registration Number: NCT04080609
• Lead Sponsor: Hua Medicine Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-27
• Primary Completion: 2018-04-17
• Study Completion: 2018-04-17
• Status Verified: 2019-09
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Last Update Submitted: 2019-09-04
• Study First Posted: 2019-09-06
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Body weight ≥ 50 kg (male) or ≥ 45 kg (female)
• BMI within 19～26 kg/m2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cmax	up to 96 hours	Peak plasma concentration
AUClast	up to 96 hours	Area under the plasma concentration curve

Trial Locations

Locations (1)

Central Hospital of Xuhui District; 🇨🇳 Shanghai, Shanghai, China