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

AstraZeneca

Status and phase: Completed; Phase 1

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

Treatments: Drug: 5-mg saxagliptin/500 mg metformin; Drug: 5-mg saxagliptin/1000 mg metformin; Drug: Diabex; Drug: Onglyza (saxagliptin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01441869

D1681C00004

Details and patient eligibility

About

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

Full 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

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

A

Experimental group

Description:

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

Treatment:

Drug: Diabex

Drug: Diabex

Drug: Onglyza (saxagliptin)

B

Experimental group

Description:

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

Treatment:

Drug: 5-mg saxagliptin/1000 mg metformin

Drug: Onglyza (saxagliptin)

C

Experimental group

Description:

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

Treatment:

Drug: Diabex

Drug: Diabex

D

Experimental group

Description:

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

Treatment:

Drug: 5-mg saxagliptin/500 mg metformin