Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
Study identifier:CV181-162
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Bioequivalence Study of Fixed Dose Combinations of Saxagliptin/Metformin extended release (XR) relative to co-administration of the individual components in Healthy Subjects in the Fasted and Fed States
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Saxagliptin/metformin fixed-dose combination (FDC), Saxagliptin, Metformin extended-release (XR), Saxagliptin/Metformin FDC, Metformin
Sex
All
Actual Enrollment
112
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jun 2011
Primary Completion Date: 01 Nov 2011
Study Completion Date: 01 Nov 2011
Study design
Allocation: Randomized
Endpoint Classification: Bio-equivalence 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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| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: Treatments A,B/B,A Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days. Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A). | Drug: Saxagliptin/metformin fixed-dose combination (FDC) Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day Other Name: Onglyza/Glucophage extended release (XR) Drug: Saxagliptin Tablet, oral, 5 mg, once on Day 1 only, 1 day Other Name: Onglyza Drug: Metformin extended-release (XR) Tablet, oral, 500 mg, once on Day 1 only, 1 day Other Name: Glifage XR |
| Experimental: Arm 2: Treatments C,D/D,C Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days. Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C). | Drug: Saxagliptin/metformin fixed-dose combination (FDC) Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day Other Name: Onglyza/Glucophage extended release (XR) Drug: Saxagliptin Tablet, oral, 5 mg, once on Day 1 only, 1 day Other Name: Onglyza Drug: Metformin extended-release (XR) Tablet, oral, 500 mg, once on Day 1 only, 1 day Other Name: Glifage XR |
| Experimental: Arm 3: Treatments E, F/F,E Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days. Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E). | Drug: Saxagliptin Tablet, oral, 5 mg, once on Day 1 only, 1 day Other Name: Onglyza Drug: Saxagliptin/Metformin FDC Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day Other Name: Onglyza/Glucophage XR Drug: Metformin Tablet, oral, 1000 mg, once on Day 1 only, 1 day Other Name: Glifage XR |
| Experimental: Arm 4: Treatments G,H/H,G Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days. Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G). | Drug: Saxagliptin Tablet, oral, 5 mg, once on Day 1 only, 1 day Other Name: Onglyza Drug: Saxagliptin/Metformin FDC Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day Other Name: Onglyza/Glucophage XR Drug: Metformin Tablet, oral, 1000 mg, once on Day 1 only, 1 day Other Name: Glifage XR |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
