| Trial ID: | L6740 |
| Source ID: | NCT02821871
|
| Associated Drug: |
Sp2086
|
| Title: |
the Food Effect Pharmacokinetic, Material Balance and Metabolite Identification of SP2086 in Healthy Volunteers
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: SP2086|DIETARY_SUPPLEMENT: high fat diet
|
| 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 12|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 12|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 SP2086., up to Day 12|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 SP2086., up to Day 12|Cumulative percentage drainage of SP2086 in urine, up to Day 12|Cumulative percentage drainage of SP2086 in fecal, up to Day 12 | Secondary: The number of volunteers with adverse events as a measure of safety and tolerability, up to Day 12
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-03
|
| Completion Date: |
2016-09
|
| Results First Posted: |
|
| Last Update Posted: |
2016-07-04
|
| Locations: |
The First Hospital of Jilin University, Changchun, Jilin, 130021, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02821871
|
