Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin (Drug); Glimepiride (Drug); Dapagliflozin + Glimepiride (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com
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
Clinical Details
Official title: Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together
Secondary outcome: Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepirideRecorded adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com
Local Institution, Vicente Lopez, Buenos Aires 1602, Argentina; Recruiting
Site 002
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: May 2008
Ending date: November 2008
Last updated: October 20, 2008
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