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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01441869
• Date of registration: 26/09/2011
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin Produc
• Scientific title: 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
• Date of first enrolment: October 2011
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01441869
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Miriana Kujacic, MD
• Affiliation: AstraZeneca Mölndal, Sweden

• Name: Peter Öhman, MD
• Affiliation: Astrazeneca, Wilmington, US

• Name: Phil Leese, MD
• Affiliation: Quintiles, Inc. Overland Park US

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Drug: 5-mg saxagliptin/500 mg metformin

Drug: Diabex

Drug: 5-mg saxagliptin/1000 mg metformin

Drug: Onglyza (saxagliptin)

Primary Outcome(s)

PK Saxagliptin: Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss) [Time Frame: At day 5 to day 6 at visit 2 or 3]

PK : Metformin Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss) [Time Frame: At day 5 to day 6 at visit 2 or 3]

Secondary Outcome(s)

Safety will be assessed by the incidence, severity, and relatedness of adverse events. [Time Frame: From day -1 visit 2 until performed follow up ( Approximately 30 days)]

PK : Saxagliptin 5-hydroxy Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss) [Time Frame: At day 5 to day 6 at visit 2 or 3]

Secondary ID(s)

D1681C00004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors