Drug Interaction With Metformin

December 19, 2016 updated by: AstraZeneca

Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects

The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Bristol-Myers Squibb Clinical Pharmacology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2

Exclusion Criteria:

  • Unwilling to use acceptable method of birth control
  • current or recent (within 1 month) smoker
  • abnormal liver function tests
  • presence of edema
  • history of diabetes mellitus
  • history of heart failure or renal insufficiency
  • history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections
  • history of Hepatitis C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Dapagliflozin
Tablets, Oral, 20 mg, once daily single dose
Active Comparator: 2
Drug: Metformin
Tablets, Oral, 1000 mg, once daily, single dose
Active Comparator: 3
Drug: Dapagliflozin + Metformin

Tablets, Oral, once daily, single dose

Dapagliflozin: 20 mg

Metformin: 1000 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment
Time Frame: measures taken daily throughout the study
measures taken daily throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment
Time Frame: measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period)
measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 18, 2007

First Submitted That Met QC Criteria

October 18, 2007

First Posted (Estimate)

October 19, 2007

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB102-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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