| Trial ID: | L5969 |
| Source ID: | NCT02113163
|
| Associated Drug: |
Metformin Eicosapentaenoate
|
| Title: |
PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Non-Insulin-Dependent|Hypertriglyceridemia
|
| Interventions: |
DRUG: Metformin Eicosapentaenoate|DRUG: Metformin HCl and Vascepa
|
| Outcome Measures: |
Primary: AUC following single and repeat single oral administration of metformin eicosapentaenoate, metformin hydrochloride and Vascepa, PK samples at 0, 0.5, 1, 2, 4, 8, and 12 hours following drug administration |
|
| Sponsor/Collaborators: |
Sponsor: Thetis Pharmaceuticals LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-03
|
| Completion Date: |
2014-07
|
| Results First Posted: |
|
| Last Update Posted: |
2022-05-02
|
| Locations: |
Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02113163
|
