MedDataX Logo

Drug Interaction With Metformin

NCT ID: NCT00546741

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Male and Female Subjects

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diabetes,NOS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 20 mg, once daily single dose

2

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Tablets, Oral, 1000 mg, once daily, single dose

3

Group Type ACTIVE_COMPARATOR

Dapagliflozin + Metformin

Intervention Type DRUG

Tablets, Oral, once daily, single dose

Dapagliflozin: 20 mg

Metformin: 1000 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapagliflozin

Tablets, Oral, 20 mg, once daily single dose

Intervention Type DRUG

Metformin

Tablets, Oral, 1000 mg, once daily, single dose

Intervention Type DRUG

Dapagliflozin + Metformin

Tablets, Oral, once daily, single dose

Dapagliflozin: 20 mg

Metformin: 1000 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bristol-Myers Squibb Clinical Pharmacology Unit

Hamilton, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3638&filename=MB102026%20_Redacted%20_CSR%20_synopsis.pdf

MB102026 \_Redacted \_CSR \_synopsis

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MB102-026

Identifier Type: -

Identifier Source: org_study_id