drugset / Trial / NCT02113163
PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-03
- Primary completion
- 2014-06
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 500 mg | Oral |
| Comparator | Metformin | Small molecule | 1000 mg | Oral |
| Comparator | icosapent ethyl | Small molecule | 1000 mg | Oral |
| Comparator | icosapent ethyl | Small molecule | 2000 mg | Oral |
| Comparator | metformin eicosapentaenoate | Unknown | 1500 mg | Oral |
| Comparator | metformin eicosapentaenoate | Unknown | 3000 mg | Oral |