Bioequivalence Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Drug: Saxagliptin/Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01874080

CV181-208

Details and patient eligibility

About

The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly

Full description

Primary Purpose:

Other: Protocol designed to demonstrate the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana and the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana in healthy human subjects under fed conditions

Enrollment: 56 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects, 18-45 years of age
• Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive
• Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product

Exclusion criteria

• Any significant acute or chronic medical illness
• Estimated creatinine clearance of <60 mL/min as calculated using the Modification of Diet in Renal Disease method Current or recent (within 3 months of study drug administration)
• Gastrointestinal (GI) disease that could affect the absorption of study drug
• Inability to tolerate oral medication
• History of allergies or adverse reactions to DPP4 inhibitors or Metformin or related compounds
• Current smoker or recent (within 6 months of study drug administration) history of regular tobacco use (positive cotinine test)

Trial design

56 participants in 4 patient groups

Arm A: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)

Experimental group

Description:

Saxagliptin 5 mg /Metformin 1000 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day 1 of Periods 1 and 2

Treatment:

Drug: Saxagliptin/Metformin

Arm B: Saxagliptin/Metformin XR FDC (Mt. Vernon)

Experimental group

Description:

Saxagliptin 5 mg/Metformin 1000 mg (Mt. Vernon) tablet by mouth once daily on Day 1 of Periods 1 and 2

Treatment:

Drug: Saxagliptin/Metformin

Arm C: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)

Experimental group

Description:

Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day1 of Periods 1 and 2

Treatment:

Drug: Saxagliptin/Metformin

Arm D: Saxagliptin/Metformin XR FDC (Mt. Vernon)

Experimental group

Description:

Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon) tablet by mouth once daily Day 1 of Periods 1 and 2

Treatment:

Drug: Saxagliptin/Metformin