NCT02113163

PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Thetis Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Non-Insulin-Dependent
• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Metformin Eicosapentaenoate
DRUG	Metformin HCl and Vascepa

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2014-04-14
• Last updated: 2022-05-02

Locations

1 site across 1 country: United States