Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: saxagliptin; Drug: saxagliptin + metformin XR (FDC tablet); Drug: metformin XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01192139

CV181-111

Details and patient eligibility

About

The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana [IN]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, IN) in fed healthy subjects.

Full description

This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/500 mg metformin extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, Indiana)

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
• Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive
• Ages 18 to 45, inclusive

Exclusion criteria

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
• Major surgical procedure within 4 weeks prior to randomization
• Positive serology test for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease
• History of gastrointestinal disease within the past 3 months
• Any clinically significant medical condition that could potentially affect your participation in the study and/or personal well-being, as judged by the investigator
• Donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization
• Unable to tolerate oral and/or intravenous (IV) medications
• Unable to tolerate the puncturing of veins for drawing of blood
• Known allergy or hypersensitivity to any component of the study medication
• History of any significant drug allergies (such as anaphylaxis or hepatotoxicity)
• Used any prescription drugs or over the counter products to control acid (for example, Prevacid, Mylanta or Rolaids) within 4 weeks prior to randomization
• Used any other drugs including over the counter medications and herbal preparations within 1 week prior to randomization
• Taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization

Trial design

30 participants in 3 patient groups

5 mg saxagliptin + a single 500 mg metformin XR tablet

Experimental group

Treatment:

Drug: metformin XR

Drug: saxagliptin

FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fed)

Experimental group

Description:

under fed state

Treatment:

Drug: saxagliptin + metformin XR (FDC tablet)

FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fasting)

Experimental group

Description:

under fasted state

Treatment:

Drug: saxagliptin + metformin XR (FDC tablet)