Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
Study identifier:CV181-081
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 500 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Co-administration of Saxagliptin and Metformin IR, Fasted, Saxagliptin/Metformin, Fasting, Co-administration of Saxagliptin and Metformin IR, Fed, Saxagliptin/Metformin, Fed
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
19 Years - 45 Years
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: 01 Aug 2009
Study Completion Date: 01 Aug 2009
Study design
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 May 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: S+ M, (fasted)> S/M (fed)> S/M (fasted)>S+M (fed) Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M [fasted]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M [fed]) followed by S/M under fasting conditions (S/M [fasted]) followed by S + M under fed conditions (S + M [fed]) | Drug: Co-administration of Saxagliptin and Metformin IR, Fasted Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions Other Name: Onglyza Drug: Saxagliptin/Metformin, Fasting Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions Other Name: Onglyza Other Name: Glucophage Drug: Co-administration of Saxagliptin and Metformin IR, Fed Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions Drug: Saxagliptin/Metformin, Fed Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions |
| Experimental: S/M (fasted)> S+M (fasted)> S+M (fed)> S/M (fed) Participants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed) | Drug: Co-administration of Saxagliptin and Metformin IR, Fasted Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions Other Name: Onglyza Drug: Saxagliptin/Metformin, Fasting Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions Other Name: Onglyza Other Name: Glucophage Drug: Co-administration of Saxagliptin and Metformin IR, Fed Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions Drug: Saxagliptin/Metformin, Fed Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions |
| Experimental: S+M (fed)> S/M (fasted) >S/M (fed)> S+M (fasted) Participants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted) | Drug: Co-administration of Saxagliptin and Metformin IR, Fasted Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions Other Name: Onglyza Drug: Saxagliptin/Metformin, Fasting Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions Other Name: Onglyza Other Name: Glucophage Drug: Co-administration of Saxagliptin and Metformin IR, Fed Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions Drug: Saxagliptin/Metformin, Fed Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions |
| Experimental: S/M (fed)> S+M (fed)> S+M (fasted)> S/M (fasted) Participants were randomized to receive S/M (fed) followed by S+M (fed) followed by S+M (fasted) followed by S/M (fasted) | Drug: Co-administration of Saxagliptin and Metformin IR, Fasted Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions Other Name: Onglyza Drug: Saxagliptin/Metformin, Fasting Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions Other Name: Onglyza Other Name: Glucophage Drug: Co-administration of Saxagliptin and Metformin IR, Fed Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions Drug: Saxagliptin/Metformin, Fed Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
