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Clinical Trial Details

Trial ID: L4568
Source ID: NCT03329118
Associated Drug: Shr3824, Simvastatin
Title: Drug-drug Interaction Between Simvastatin and SHR3824
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: SHR3824, Simvastatin
Outcome Measures: Primary: The maximum plasma concentration (Cmax) of SHR3824, Cmax (a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin ., At protocol-specified times up to Day 7 and Day 8|The area under the plasma concentration-time curve (AUC) of SHR3824, AUC(a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin ., At protocol-specified times up to Day 7 and Day 8|The area under the plasma concentration-time curve (AUC) of Simvastatin and simavastatin acid ., AUC(a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with SHR3824 ., At protocol-specified times up to Day 1 and Day 8|The maximum plasma concentration (Cmax) of simvastatin and simavastatin acid., Cmax (a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with Simvastatin ., At protocol-specified times up to Day 1 and Day 8|The number of volunteers with adverse events as a measure of safety and tolerability., up to day 15 |
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-11-24
Completion Date: 2017-12-08
Results First Posted:
Last Update Posted: 2017-11-09
Locations:
URL: https://clinicaltrials.gov/show/NCT03329118