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

A Single Dose, Open Label, Drug-drug Interaction Study to Investigate the Pharmacokinetics, Pharmadynamics and Safety of HMS5552 Administered Alone or in Combination With Itraconazole in Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04080596

Enrollment

Registered

2019-09-06

Start date

2017-10-13

Completion date

2017-12-05

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

Interventions

DRUGDorzagliatin

GKA for T2DM currently under clinical development

Study design

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

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