Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin Produc

NCT ID: NCT01441869

Last Updated: 2012-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2011-12-31

Brief Summary

Study in healthy subjects to measure amount of drug in blood after dosing with different saxagliptin / metformin products.

Detailed Description

Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets Coadministered to Healthy Subjects in the Fed State During Steady-state Administration

Conditions

Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A

5-mg Onglyza (saxagliptin) tablet +1000-mg Diabex extended release tablet

Group Type: EXPERIMENTAL

Onglyza (saxagliptin)

Intervention Type: DRUG

Oral tablets, 5 mg , single dose

Diabex

Intervention Type: DRUG

Extended release oral tablets, 1000 mg, single dose

B

5-mg saxagliptin/1000 mg metformin extended release fixed dose combination tablet

Group Type: EXPERIMENTAL

Onglyza (saxagliptin)

Intervention Type: DRUG

Oral tablets, 5 mg , single dose

5-mg saxagliptin/1000 mg metformin

Intervention Type: DRUG

Extended release fixed dose combination tablet, single dose

C

5-mg Onglyza (saxagliptin) tablet + 500-mg Diabex extended release tablet

Group Type: EXPERIMENTAL

Diabex

Intervention Type: DRUG

Extended release oral tablets, 500 mg, single dose

D

5-mg saxagliptin/500 mg metformin extended release fixed dose combination tablet

Group Type: EXPERIMENTAL

5-mg saxagliptin/500 mg metformin

Intervention Type: DRUG

Extended release fixed dose combination tablet, single dose

Interventions

Onglyza (saxagliptin)

Oral tablets, 5 mg , single dose

Intervention Type: DRUG

Diabex

Extended release oral tablets, 1000 mg, single dose

Intervention Type: DRUG

5-mg saxagliptin/1000 mg metformin

Extended release fixed dose combination tablet, single dose

Intervention Type: DRUG

Diabex

Extended release oral tablets, 500 mg, single dose

Intervention Type: DRUG

5-mg saxagliptin/500 mg metformin

Extended release fixed dose combination tablet, single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provision of signed and dated informed consent prior to any study specific procedures
• Males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and a body mass index (BMI) between 18 and 35 kg/m2, inclusive
• Females must have a negative urine pregnancy test at screening and negative serum pregnancy test on admission to the unit, must not be lactating, and must be using an acceptable method of contraception for at least 1 month before dosing
• Female volunteers of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, ie, less than 1% per year
• Oral contraceptive and hormone replacement medications are allowed in this study if used together with a barrier contraceptive method.

Exclusion Criteria

• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
• History or presence of gastrointestinal, hepatic, renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
• Glomerular filtration rate of less than 60 mL/min (to be estimated at screening only)
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product (IP)
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator (eg, seasonal allergies) or history of hypersensitivity to drugs with a similar chemical structure or class to saxagliptin or metformin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miriana Kujacic, MD

Role: STUDY_CHAIR

AstraZeneca Mölndal, Sweden

Phil Leese, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc. Overland Park US

Peter Öhman, MD

Role: STUDY_DIRECTOR

Astrazeneca, Wilmington, US

Locations

Research Site

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

D1681C00004

Identifier Type: -

Identifier Source: org_study_id