DDI Study Between Dorzagliatin and Rifampicin

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04080609

Enrollment

Registered

2019-09-06

Start date

2018-03-27

Completion date

2018-04-17

Last updated

2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Interaction

Brief summary

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

Interventions

DRUGDorzagliatin

GKA currently under clinical development

Study design

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026