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Clinical Trial Details

Trial ID: L1964
Source ID: NCT02354027
Associated Drug: Shr3824 Metformin
Title: The Drug-drug Interaction of SHR3824 and Metformin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: SHR3824 metformin
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 administration of a single dose of metformin., At protocol-specified times up to Day 9.|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 administration of a single dose of metformin., At protocol-specified times up to Day 9.|The maximum plasma concentration (Cmax) of metformin., Cmax (a measure of the body's exposure to metformin) will be compared. before and after administration of multiple doses of SHR3824, At protocol-specified times up to Day 9.|The area under the plasma concentration-time curve (AUC) of metformin, AUC (a measure of the body's exposure to metformin) will be compared before and after administration of multiple doses of SHR3824., At protocol-specified times up to Day 9. | Secondary: The number of volunteers with adverse events as a measure of safety and tolerability., Up tp day 9.
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: 2014-09
Completion Date: 2015-01
Results First Posted:
Last Update Posted: 2015-07-16
Locations:
URL: https://clinicaltrials.gov/show/NCT02354027