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Assessing the PK of Met DR, Met IR, and Met XR in Healthy Subjects

NCT02291510 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-12-02

Study results available
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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.

Conditions

  • Healthy Subjects

Interventions

DRUG

Met DR

metformin delayed-release tablets

DRUG

Met XR

metformin extended-release tablets

DRUG

Met IR

metformin immediate-release tablets

Sponsors & Collaborators

  • Elcelyx Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Rasmussen, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02291510 on ClinicalTrials.gov