Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects
Study identifier:MB102-037
ClinicalTrials.gov identifier:NCT00842556
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Dapagliflozin, Glimepiride, Sitagliptin
Sex
All
Actual Enrollment
18
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Mar 2009
Primary Completion Date: 01 May 2009
Study Completion Date: 01 May 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
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 |
|---|---|
| Active Comparator: Dapagliflozin | Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148 |
| Active Comparator: Glimepiride | Drug: Glimepiride Tablets, Oral, 4 mg, Single Dose Other Name: Amaryl |
| Active Comparator: Dapagliflozin + Glimepiride | Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148 Drug: Glimepiride Tablets, Oral, 4 mg, Single Dose Other Name: Amaryl |
| Active Comparator: Sitagliptin | Drug: Sitagliptin Tablets, Oral, 100 mg, Single Dose Other Name: Januvia |
| Active Comparator: Dapagliflozin + Sitagliptin | Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148 Drug: Sitagliptin Tablets, Oral, 100 mg, Single Dose Other Name: Januvia |
Contacts
Contact Backup
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Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
