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Clinical Trial Details

Trial ID: L3357
Source ID: NCT02815722
Associated Drug: Sp2086
Title: The Drug-drug Interaction of SP2086 and Simvastatin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: SP2086|DRUG: Simvastatin
Outcome Measures: Primary: The maximum plasma concentration (Cmax) of SP2086, Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086, up to Day 27|The maximum plasma concentration (Cmax) of SP2086 acid, Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086, up to Day 27|The maximum plasma concentration (Cmax) of Simvastatin, Cmax (a measure of the body's exposure to Simvastatin) will be compared before and after administration of multiple doses of Simvastatin, up to Day 27|The area under the plasma concentration-time curve (AUC) of SP2086, AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086, up to Day 27|The area under the plasma concentration-time curve (AUC) of SP2086 acid, AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086, up to Day 27|The area under the plasma concentration-time curve (AUC) of Simvastatin, AUC (a measure of the body's exposure to Simvastatin) will be compared before and after administration of multiple doses of Simvastatin, up to Day 27 | Secondary: The number of volunteers with adverse events as a measure of safety and tolerability, up to Day 27
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-07
Completion Date: 2014-05
Results First Posted:
Last Update Posted: 2016-06-28
Locations: People's Liberation Army General Hospital of Chengdu Military Region, Chengdu, China
URL: https://clinicaltrials.gov/show/NCT02815722