Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and metformin, 1000-mg XR tablets administered together in both the fasted and fed states.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Metformin; Saxagliptin

Criteria

Key Inclusion Criteria:

• Healthy men and women

• 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.

Key Exclusion Criteria:

• Any significant acute or chronic medical illness.

• 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