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Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00770302
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : July 9, 2009
Bristol-Myers Squibb
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Brief Summary:
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses of 5 mg saxagliptin in healthy Chinese subjects.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Saxagliptin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label, Pharmacokinetic Study of Single and Multiple Doses of 5 mg Saxagliptin in Healthy Chinese Subjects Living in China
Study Start Date : October 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin

Intervention Details:
  • Drug: Saxagliptin
    Oral tablet, once daily for 1 (single-dose) and 5 (multiple-dose) days
    Other Name: ONGLYZA™

Primary Outcome Measures :
  1. Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin [ Time Frame: Multiple timepoints during 9 days ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables for saxagliptin's active metabolite BMS-510849 after single and multiple oral doses of 5 mg saxagliptin [ Time Frame: Multiple time points during 9 days ]
  2. Safety variables (adverse events reported, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests after single and multiple oral doses of 5 mg saxagliptin [ Time Frame: Multiple time points during 10 days (including measurements before dosing) ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men or women (not of childbearing potential) of Chinese ethnicity
  • Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2
  • Must have normal physical examination, laboratory values, ECG, pulse and blood pressure unless the investigator considers an abnormality to not be clinically significant.

Exclusion Criteria:

  • History of clinically significant hypoglycaemia (low blood sugar levels)
  • Women who are pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00770302

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Research Site
Beijing, China
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Peter Öhman, MD, PhD AstraZeneca
Study Chair: Deborah Price, MSc AstraZeneca
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Peter Öhman, MD, PhD, Medical Science Director, AstraZeneca Pharmaceuticals Identifier: NCT00770302    
Other Study ID Numbers: D1680C00004
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: July 9, 2009
Last Verified: July 2009
Keywords provided by AstraZeneca:
DPP-4 inhibitors
Additional relevant MeSH terms:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents