Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

NCT00562250 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-10-17

No results posted yet for this study

Summary

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

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Dapagliflozin

Tablets, Oral, 20 mg, once daily, single dose

DRUG

Glimepiride

Tablets, Oral, 4 mg, once daily, single dose

DRUG

Dapagliflozin + Glimepiride

Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Argentina

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 NCT00562250 on ClinicalTrials.gov