DDI Study Between Dorzagliatin and Rifampicin

Hua Medicine

Status and phase: Completed; Phase 1

Conditions: Drug Interaction

Treatments: Drug: Dorzagliatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04080609

HMM0108

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Sequential arm

Experimental group

Description:

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

Treatment:

Drug: Dorzagliatin