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NCT02113163 · ClinicalTrials.gov registry record · Phase 1
PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
A Phase 1 study of Hypertriglyceridemia and Diabetes Mellitus, Non-Insulin-Dependent, sponsored by Thetis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT02113163 is a Phase 1 study of Hypertriglyceridemia and Diabetes Mellitus, Non-Insulin-Dependent that has completed, run by Thetis Pharmaceuticals. The registered enrollment target is 32 participants, below the 175-participant average among 25 other Hypertriglyceridemia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02113163, a Phase 1 study of Hypertriglyceridemia and Diabetes Mellitus, Non-Insulin-Dependent, has completed, sponsored by Thetis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Metformin Eicosapentaenoate
- DRUG Metformin HCl and Vascepa
Study Locations (1)
Louisiana
- Pennington Biomedical Research Center - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02113163
The ClinicalTrials.gov registry entry for NCT02113163 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 175-participant average among 25 other Hypertriglyceridemia trials with a reported enrollment target (82% lower). The listed sponsor is Thetis Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hypertriglyceridemia appearing as the primary indexed condition, and to 2 interventions - of which Metformin Eicosapentaenoate is the first listed.
NCT02113163 reports 1 study location spanning 1 distinct geographic area - top geographies include Louisiana.
Frequently Asked Questions
What is clinical trial NCT02113163 about?
NCT02113163 is a clinical study titled "PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA". 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) unde...
What is the current status of trial NCT02113163?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2014-03. Estimated completion is 2014-07.
What conditions does trial NCT02113163 study?
This clinical trial studies the following conditions: Hypertriglyceridemia, Diabetes Mellitus, Non-Insulin-Dependent.
What interventions are being tested in trial NCT02113163?
The interventions under investigation include: Metformin Eicosapentaenoate (DRUG), Metformin HCl and Vascepa (DRUG).
Who is sponsoring clinical trial NCT02113163?
This trial is sponsored by Thetis Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02113163 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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