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)

NCT ID: NCT01192139

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2009-12-31

Brief Summary

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.

Detailed 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)

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

5 mg saxagliptin + a single 500 mg metformin XR tablet

Group Type: EXPERIMENTAL

saxagliptin

Intervention Type: DRUG

Tablets, Oral, 5 mg, once daily, Single dose

metformin XR

Intervention Type: DRUG

Tablets, Oral, 500 mg. once daily, Single dose

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

under fed state

Group Type: EXPERIMENTAL

saxagliptin + metformin XR (FDC tablet)

Intervention Type: DRUG

Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose

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

under fasted state

Group Type: EXPERIMENTAL

saxagliptin + metformin XR (FDC tablet)

Intervention Type: DRUG

Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose

Interventions

saxagliptin

Tablets, Oral, 5 mg, once daily, Single dose

Intervention Type: DRUG

metformin XR

Tablets, Oral, 500 mg. once daily, Single dose

Intervention Type: DRUG

saxagliptin + metformin XR (FDC tablet)

Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose

Intervention Type: DRUG

Other Intervention Names

Onglyza; Glucophage XR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Ppd Development, Lp

Austin, Texas, United States

Countries

United States

References

Boulton DW, Smith CH, Li L, Huang J, Tang A, LaCreta FP. Bioequivalence of saxagliptin/metformin extended-release (XR) fixed-dose combination tablets and single-component saxagliptin and metformin XR tablets in healthy adult subjects. Clin Drug Investig. 2011;31(9):619-30. doi: 10.2165/11590290-000000000-00000.

Reference Type: DERIVED

PMID: 21819160 (View on PubMed)

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CV181-111

Identifier Type: -

Identifier Source: org_study_id