Drug Interaction With Metformin

NCT00546741 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-12-20

No results posted yet for this study

Summary

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

Conditions

  • Healthy Male and Female Subjects

Interventions

DRUG

Dapagliflozin

Tablets, Oral, 20 mg, once daily single dose

DRUG

Metformin

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

DRUG

Dapagliflozin + Metformin

Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00546741 on ClinicalTrials.gov