Study identifier:CV181-341
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Bioequivalence Study of 2.5-mg Saxagliptin/5-mg Dapagliflozin and 5-mg Saxagliptin/10-mg Dapagliflozin Fixed Dose Combination Tablets Relative to Coadministration of Their Respective Individual Components in Healthy Subjects and a Characterization of the Effect of Food on the Fixed Dose Combination Tablets
Type 2 Diabetes Mellitus
Phase 1
Yes
Saxagliptin, Dapagliflozin, Saxagliptin/Dapagliflozin FDC
All
72
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verified 01 Apr 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Astra-Zeneca
No locations available
Arms | Assigned Interventions |
---|---|
Other: Treatment A: Saxagliptin 2.5mg+Dapagliflozin 5mg; Fasting Saxagliptin 2.5 mg tablet and Dapagliflozin 5 mg tablet single dose orally on Day 1 in one of 3 periods | - |
Other: Treatment B: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fasting Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods | - |
Other: Treatment C: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fed Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods | - |
Other: Treatment D: Saxagliptin 5mg+Dapagliflozin 10mg; Fasting Saxagliptin 5 mg tablet and Dapagliflozin 10 mg tablet single dose orally for on Day 1 in one of 3 periods | - |
Other: Treatment E: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fasting Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods | - |
Other: Treatment F: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fed Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods | - |