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Clinical Trial Details

Trial ID: L3408
Source ID: NCT02822534
Associated Drug: Sp2086
Title: The Pharmacokinetics and Pharmacodynamics Study of Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients
Acronym:
Status: UNKNOWN
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 a single dose of SP2086, up to Day 13|The steady-state plasma concentration (Css) of SP2086, Css (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086, up to Day 13|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 SP2086, up to Day 13|The steady-state plasma concentration (Css) of SP2086 acid, Css (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 13|The maximum urine 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 SP2086, up to Day 13|The steady-state urine concentration (Css) of SP2086, Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086, up to Day 13|The maximum urine 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 SP2086, up to Day 13|The steady-state urine concentration (Css) of SP2086 acid, Css (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 13 | Secondary: The number of volunteers with adverse events as a measure of safety and tolerability, up to Day 13
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-04
Completion Date:
Results First Posted:
Last Update Posted: 2016-07-04
Locations: the First Hosital of Jilin University, Changchun, Jilin, China
URL: https://clinicaltrials.gov/show/NCT02822534