Clinical Trial: The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase I, Single-Center, Open-Label, Single-Group Study to Evaluate Potential Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat and Between SHR4640 and Colchicine in Patients W
Brief Summary: The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.
Detailed Summary:
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Current Primary Outcome:
- Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma [ Time Frame: Clinical significant changes from baseline up to Day 8 ]PK profile
- Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma [ Time Frame: Clinical significant changes from baseline up to Day 8 ]PK profile
- Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma [ Time Frame: Clinical significant changes from baseline up to Day 8 ]PK profile
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of Adverse events [ Time Frame: Clinical significant changes from Day-14 up to Day 16 ]Safety issue
- Changes in Laboratory Values [ Time Frame: Clinical significant changes from Day-14 up to Day 16 ]Safety issue
- Changes in Electrocardiogram [ Time Frame: Clinical significant changes from Day-14 up to Day 16 ]Safety issue
- Changes in Vital Signs Parameters [ Time Frame: Clinical significant changes from Day-14 up to Day 16 ]Safety issue
Original Secondary Outcome:
- Incidence of Adverse events [ Time Frame: Clinical significant changes from D-14 up to Day 16 ]Safety issue
- Changes in Laboratory Values [ Time Frame: Clinical significant changes from D-14 up to Day 16 ]Safety issue
- Changes in Electrocardiogram [ Time Frame: Clinical significant changes from D-14 up to Day 16 ]Safety issue
- Changes in Vital Signs Parameters [ Time Frame: Clinical significant changes from D-14 up to Day 16 ]Safety issue
Information By: Jiangsu HengRui Medicine Co., Ltd.
Dates:
Date Received: February 27, 2017
Date Started: February 17, 2017
Date Completion: June 2017
Last Updated: May 3, 2017
Last Verified: May 2017