| Trial ID: | L3562 |
| Source ID: | NCT02447601
|
| Associated Drug: |
Pex168
|
| Title: |
Evaluate the Pharmacokinetics of Simvastatin When Coadministered With PEX168 in Healthy Adult Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: PEX168|DRUG: Simvastatin
|
| Outcome Measures: |
Primary: Plasma concentrations of simvastatin and simvastatin acid., Plasma concentrations of simvastatin and simvastatin acid, and to calculate the pharmacokinetic parameters: Tmax, Cmax, AUC0-t, AUC0-∞, λz, t1 / 2, Vd / F, CL / F, etc., Baseline to Day34 | Secondary: Incidence of adverse events and serious adverse events, Baseline to Day67
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2015-03-30
|
| Completion Date: |
2015-08-11
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-24
|
| Locations: |
Shanghai Mental Health Center (SMHC), Shanghai, Shanghai, 200122, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02447601
|
