Study identifier:D1681C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets Coadministered to Healthy Subjects in the Fed State During Steady-state Administration
bioequivalence, log-transformed AUCss and Cmax,ss values for saxagliptin and metformin
Phase 1
Yes
Onglyza (saxagliptin), Diabex, 5-mg saxagliptin/1000 mg metformin, 5-mg saxagliptin/500 mg metformin
All
28
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Nov 2013 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: A 5-mg Onglyza (saxagliptin) tablet +1000-mg Diabex extended release tablet | Drug: Onglyza (saxagliptin) Oral tablets, 5 mg , single dose Drug: Diabex Extended release oral tablets, 1000 mg, single dose |
Experimental: B 5-mg saxagliptin/1000 mg metformin extended release fixed dose combination tablet | Drug: Onglyza (saxagliptin) Oral tablets, 5 mg , single dose Drug: 5-mg saxagliptin/1000 mg metformin Extended release fixed dose combination tablet, single dose |
Experimental: C 5-mg Onglyza (saxagliptin) tablet + 500-mg Diabex extended release tablet | Drug: Diabex Extended release oral tablets, 500 mg, single dose |
Experimental: D 5-mg saxagliptin/500 mg metformin extended release fixed dose combination tablet | Drug: 5-mg saxagliptin/500 mg metformin Extended release fixed dose combination tablet, single dose |