| Trial ID: | L4247 |
| Source ID: | NCT02817217
|
| Associated Drug: |
Sp2086
|
| Title: |
The DDI Study of SP2086 and Valsartan
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: SP2086|DRUG: Valsartan
|
| 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 Valsartan, 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 Valsartan, up to Day 9|The maximum plasma concentration (Cmax) of Valsartan, Cmax (a measure of the body's exposure to Valsartan) 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 SP2086, AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Valsartan., 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 Valsartan., up to Day 9|The area under the plasma concentration-time curve (AUC) of Valsartan, AUC (a measure of the body's exposure to Valsartan) 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: |
2016-03
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2016-06-29
|
| Locations: |
People's Liberation Army General Hospital of Chengdu Military Region, Chengdu, Sichuan, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02817217
|
