| Trial ID: | L6011 |
| Source ID: | NCT02500485
|
| Associated Drug: |
Shr3824, Sp2086
|
| Title: |
The Drug-drug Interaction of SHR3824 and SP2086
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: SHR3824, SP2086
|
| 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 multiple doses of SP2086., At protocol-specified times up to Day 14 and Day 18.|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 multiple doses of SP2086., At protocol-specified times up to Day 14 and Day 18.|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 SHR3824, At protocol-specified times up to Day 4 and Day 18.|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 SHR3824., At protocol-specified times up to Day 4 and Day 18.|The number of volunteers with adverse events as a measure of safety and tolerability., Up tp day 18. |
|
| 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: |
2015-05
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2015-11-25
|
| Locations: |
Phase I Unit of Tongji Hospital affilated Tongji Medical School of Huangzhong Science and Thechnology, Wuhan, Hubei, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02500485
|
