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Clinical Trial Details

Trial ID: L3233
Source ID: NCT02813863
Associated Drug: Sp2086
Title: The Drug-drug Interaction of SP2086 and Metformin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: SP2086|DRUG: Metformin
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 a single dose of metformin, up to Day 9|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 a single dose of metformin, up to Day 9|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 a single dose of metformin, up to Day 9|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 a single dose of metformin, 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 SP2086, 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 SP2086, up to Day 9 | Secondary: The number of volunteers with adverse events as a measure of safety and tolerability, up to Day 9
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-12
Completion Date:
Results First Posted:
Last Update Posted: 2016-06-27
Locations:
URL: https://clinicaltrials.gov/show/NCT02813863