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NCT04080596 Clinical Trial

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

Drug Interaction Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04080596
Other study ID # HMM0107
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 13, 2017
Est. completion date December 5, 2017

Study information
Verified date September 2019
Source Hua Medicine Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date December 5, 2017
Est. primary completion date December 5, 2017
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dorzagliatin
GKA for T2DM currently under clinical development

Locations
Country Name City State
China The 2nd Hospital of Jilin University Changchun Jilin

Sponsors (1)
Lead Sponsor Collaborator
Hua Medicine Limited

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax Peak concentration up to 96 hours
Primary AUClast Area under the curve up to 96 hours
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