CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Met DR +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02291510
NCT02291510Phase 1Completed
CompareCT.gov

A Randomized, Crossover Study Assessing the Pharmacokinetics of EFB0027 Versus ETB0015 and ETB0014 in Healthy Subjects

Elcelyx Therapeutics, Inc.·interventional·Posted Nov 14, 2014·Updated Dec 2, 2016

In Brief

A Phase 1 clinical trial evaluating Met DR, Met XR, and 1 other intervention for Healthy Subjects. Completed, enrolled 20 participants.

Detailed Summary

This study compared the pharmacokinetics (PK) and assessed the safety of delayed-release metformin (Met DR, EFB0027) at two dosage levels, immediate-release metformin (Met IR, ETB0015), and extended-release metformin (Met XR, ETB0014) in healthy subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 14, 2014
Enrollment StartOct 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.6 years ago

Interventions

Met DRdrug

metformin delayed-release tablets

Met XRdrug

metformin extended-release tablets

Met IRdrug

metformin immediate-release tablets