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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01441869
First received: September 26, 2011
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin
Drug: Onglyza (saxagliptin)
Drug: Diabex
Drug: 5-mg saxagliptin/1000 mg metformin
Drug: 5-mg saxagliptin/500 mg metformin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
5-mg Onglyza (saxagliptin) tablet +1000-mg Diabex extended release tablet
Drug: Onglyza (saxagliptin)
Oral tablets, 5 mg , single dose
Drug: Diabex
Extended release oral tablets, 1000 mg, single dose
Experimental: B
5-mg saxagliptin/1000 mg metformin extended release fixed dose combination tablet
Drug: Onglyza (saxagliptin)
Oral tablets, 5 mg , single dose
Drug: 5-mg saxagliptin/1000 mg metformin
Extended release fixed dose combination tablet, single dose
Experimental: C
5-mg Onglyza (saxagliptin) tablet + 500-mg Diabex extended release tablet
Drug: Diabex
Extended release oral tablets, 500 mg, single dose
Experimental: D
5-mg saxagliptin/500 mg metformin extended release fixed dose combination tablet
Drug: 5-mg saxagliptin/500 mg metformin
Extended release fixed dose combination tablet, single dose

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441869

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Miriana Kujacic, MD AstraZeneca Mölndal, Sweden
Principal Investigator: Phil Leese, MD Quintiles, Inc. Overland Park US
Study Director: Peter Öhman, MD Astrazeneca, Wilmington, US
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01441869     History of Changes
Other Study ID Numbers: D1681C00004
Study First Received: September 26, 2011
Last Updated: February 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase 1, Healthy male volunteers, pharmacokinetics, saxagliptin/ metformin , Diabex

Additional relevant MeSH terms:
Saxagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014