Status:
COMPLETED
DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin
Lead Sponsor:
Hua Medicine Limited
Conditions:
Drug Interaction
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the impact of itraconzaole on the pharmacokinetics of Dorzagliatin.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04080596
Start Date
October 13 2017
End Date
December 5 2017
Last Update
September 6 2019
Active Locations (1)
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1
The 2nd Hospital of Jilin University
Changchun, Jilin, China, 130021