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

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

Detailed Description
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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

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

Intervention / Treatment
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* Drug: Onglyza (saxagliptin)
* Drug: Diabex
* Drug: 5-mg saxagliptin/1000 mg metformin
* Drug: Diabex
* Drug: 5-mg saxagliptin/500 mg metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>5-mg Onglyza (saxagliptin) tablet +1000-mg Diabex extended release tablet | Drug: Onglyza (saxagliptin)<br>* Oral tablets, 5 mg , single dose<br>Drug: Diabex<br>* Extended release oral tablets, 1000 mg, single dose<br>|
| Experimental: B<br>5-mg saxagliptin/1000 mg metformin extended release fixed dose combination tablet | Drug: Onglyza (saxagliptin)<br>* Oral tablets, 5 mg , single dose<br>Drug: 5-mg saxagliptin/1000 mg metformin<br>* Extended release fixed dose combination tablet, single dose<br>|
| Experimental: C<br>5-mg Onglyza (saxagliptin) tablet + 500-mg Diabex extended release tablet | Drug: Diabex<br>* Extended release oral tablets, 500 mg, single dose<br>|
| Experimental: D<br>5-mg saxagliptin/500 mg metformin extended release fixed dose combination tablet | Drug: 5-mg saxagliptin/500 mg metformin<br>* Extended release fixed dose combination tablet, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 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) |  | At day 5 to day 6 at visit 2 or 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | At day 5 to day 6 at visit 2 or 3 | 
| Safety will be assessed by the incidence, severity, and relatedness of adverse events. |  | From day -1 visit 2 until performed follow up ( Approximately 30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Healthy male volunteers, pharmacokinetics, saxagliptin/ metformin , Diabex