DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin

Hua Medicine

Status and phase: Completed; Phase 1

Conditions: Drug Interaction

Treatments: Drug: Dorzagliatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04080596

HMM0107

Details and patient eligibility

About

The purpose of this study is to investigate the impact of itraconzaole on the pharmacokinetics of Dorzagliatin.

Enrollment: 18 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 30-65
• Body weight ≥ 50 kg
• BMI ≥ 19.0 kg/m2 and ≤ 30.0 kg/m2
• HbA1c ≥ 7% and ≤ 10.5%
• FPG ≥ 7.5 mmol/L and ≤ 13.3 mmol/L

Exclusion criteria

• T1DM
• Use of prescription or OTC medications, and herbal within 14 days prior to dosing
• Blood donation
• Any surgery or treatment that may impact the ADME of the drug

Trial design

18 participants in 1 patient group

Sequential arm

Experimental group

Description:

Dorzagliatin administered alone on Day 1; after wash-out, intraconazole was administered from Day 8 to Day 15, with Dorzagliatin administered together on Day 11.

Treatment:

Drug: Dorzagliatin