Status:
COMPLETED
Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin Produc
Lead Sponsor:
AstraZeneca
Conditions:
Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 Sub...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01441869
Start Date
October 1 2011
End Date
December 1 2011
Last Update
February 8 2012
Active Locations (1)
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1
Research Site
Overland Park, Kansas, United States