Drug Interaction Study of Saxagliptin in Combination with Dapagliflozin in Healthy Participants
Study identifier:CV181-191
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Single-dose, Open-label, Randomized, 3 Period, 3 Treatment Crossover Study to Evaluate the Pharmacokinetics of Saxagliptin 5 mg and Dapagliflozin 10 mg When Coadministered to Fasted Healthy Subjects
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Saxagliptin, Dapagliflozin
Sex
All
Actual Enrollment
42
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Aug 2012
Primary Completion Date: 01 Nov 2012
Study Completion Date: 01 Nov 2012
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Apr 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Astra-Zeneca
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin) Treatment A: Saxagliptin 5mg, Tablet, Oral; Single dose Treatment B: Dapagliflozin 10mg, Tablet, Oral; single dose Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; single dose | - |
| Experimental: A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose | - |
| Experimental: B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin) Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose. Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose | - |
| Experimental: B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose | - |
| Experimental: C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose | - |
| Experimental: C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, Once daily, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose | - |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
