Pharmacokinetic Drug Interaction Study with Dapagliflozin and Glimepiride in Healthy Subjects
Study identifier:MB102-016
ClinicalTrials.gov identifier:NCT00562250
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Pharmacokinetic Drug Interaction Study with Dapagliflozin and Glimepiride in Healthy Subjects
Medical condition
Diabetes Mellitus, Type 2
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Dapagliflozin, Glimepiride, Dapagliflozin + Glimepiride
Sex
All
Actual Enrollment
11
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 May 2008
Primary Completion Date: 01 Aug 2008
Study Completion Date: 01 Aug 2008
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
