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An Open-label, Single and Repeat Single Ascending Dose Escalation Study to Compare the Pharmacokinetics of Metformin Eicosapentaenoate With Metformin Hydrochloride and Icosapent Ethyl Following Oral Administration to Healthy Volunteers
The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101.
Details
| Lead sponsor | Thetis Pharmaceuticals LLC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 32 |
| Start date | 2014-03 |
| Completion | 2014-07 |
Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Hypertriglyceridemia
Interventions
- Metformin Eicosapentaenoate
- Metformin HCl and Vascepa
Primary outcomes
- 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
Countries
United States