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Clinical Trial Details

Trial ID: L1824
Source ID: NCT02815748
Associated Drug: Sp2086
Title: The Metabolite Identification and Material Balance Study of SP2086
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: SP2086
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 96 hours|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 96 hours|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 96 hours|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 96 hours | Secondary: The number of volunteers with adverse events as a measure of safety and tolerability, up to 96 hours
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 8
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-08
Completion Date: 2015-10
Results First Posted:
Last Update Posted: 2016-07-01
Locations:
URL: https://clinicaltrials.gov/show/NCT02815748