Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
NCT ID: NCT01365091
Last Updated: 2015-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
112 participants
INTERVENTIONAL
2011-06-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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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).
Saxagliptin/metformin fixed-dose combination (FDC)
Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day
Saxagliptin
Tablet, oral, 5 mg, once on Day 1 only, 1 day
Metformin extended-release (XR)
Tablet, oral, 500 mg, once on Day 1 only, 1 day
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).
Saxagliptin/metformin fixed-dose combination (FDC)
Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day
Saxagliptin
Tablet, oral, 5 mg, once on Day 1 only, 1 day
Metformin extended-release (XR)
Tablet, oral, 500 mg, once on Day 1 only, 1 day
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).
Saxagliptin
Tablet, oral, 5 mg, once on Day 1 only, 1 day
Saxagliptin/Metformin FDC
Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day
Metformin
Tablet, oral, 1000 mg, once on Day 1 only, 1 day
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).
Saxagliptin
Tablet, oral, 5 mg, once on Day 1 only, 1 day
Saxagliptin/Metformin FDC
Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day
Metformin
Tablet, oral, 1000 mg, once on Day 1 only, 1 day
Interventions
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Saxagliptin/metformin fixed-dose combination (FDC)
Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day
Saxagliptin
Tablet, oral, 5 mg, once on Day 1 only, 1 day
Metformin extended-release (XR)
Tablet, oral, 500 mg, once on Day 1 only, 1 day
Saxagliptin/Metformin FDC
Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day
Metformin
Tablet, oral, 1000 mg, once on Day 1 only, 1 day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* women of childbearing potential who are using acceptable method of contraception
* Women who are not pregnant or nursing
* Body Mass Index (BMI) of 18 to 29.9 kg/m\^2, inclusive. BMI=weight(kg)/height(m)\^2.
Exclusion Criteria
* History of gastrointestinal (GI) disease
* Major surgery within 4 weeks of study drug administration
* Any GI surgery that could impact study drug absorption
* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within the 6 months of study drug administration.
* Blood transfusion within 3 months of study drug administration for women and within 2 months for men
* Inability to be venipunctured and/or tolerate venous access
* Current smoker or recent (within 1 month) history of regular tobacco use
* Recent (within 6 months of study drug administration) drug or alcohol abuse
* Participation in a bioequivalence study within the last 6 months of study drug administration
* Estimated creatinine clearance of \<80 mL/min using Cockcroft-Gault formula
* History of allergy to drug class or related compounds
* History of allergy to metformin or other similar acting agents
* History of any significant drug allergy
18 Years
55 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Campinas, São Paulo, Brazil
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CV181-162
Identifier Type: -
Identifier Source: org_study_id
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