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

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

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