| Trial ID: | L5850 |
| Source ID: | NCT02815787
|
| Associated Drug: |
Sp2086
|
| Title: |
The Drug -Drug Interaction of SP2086 and Glyburide
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: SP2086|DRUG: Glyburide
|
| 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 25|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 25|The maximum plasma concentration (Cmax) of Glyburide, Cmax (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide, up to Day 25|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 25|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 25|The area under the plasma concentration-time curve (AUC) of Glyburide, AUC (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide, up to Day 25 | Secondary: The number of volunteers with adverse events as a measure of safety and tolerability, up to Day 25
|
| 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: |
2014-03
|
| Completion Date: |
2014-07
|
| Results First Posted: |
|
| Last Update Posted: |
2016-06-28
|
| Locations: |
Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02815787
|
