Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

October 14, 2016 updated by: AstraZeneca
The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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

  • Argentina
    • Buenos Aires
      • Vicente Lopez, Buenos Aires, Argentina, 1602
        • Local Institution

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 subjects with BMI of 18-32 kg/m2

Exclusion Criteria:

  • Abnormal physical or lab findings
  • Allergies to any sulfonylurea or related compounds

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: Dapagliflozin
Tablets, Oral, 20 mg, once daily, single dose
ACTIVE_COMPARATOR: Arm 2
Drug: Glimepiride
Tablets, Oral, 4 mg, once daily, single dose
ACTIVE_COMPARATOR: Arm 3
Drug: Dapagliflozin + Glimepiride
Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together
Time Frame: plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose
plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride
Time Frame: for 72 hours after each administered dose
for 72 hours after each administered dose
Recorded adverse events
Time Frame: for 72 hours after each administered dose
for 72 hours after each administered dose

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

May 1, 2008

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (ESTIMATE)

November 22, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB102-016

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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