Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects
Eligibility Criteria
Inclusion
- Men and women ages 18 to 45 inclusive
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]²
Exclusion
- WOCBP who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- History of allergy to DPP4 inhibitor or related compounds
- Prior exposure to saxagliptin
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00935467
Start Date
July 1 2009
End Date
August 1 2009
Last Update
May 5 2015
Active Locations (1)
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1
Ppd Development, Lp
Austin, Texas, United States, 78744