Status:
COMPLETED
Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- History of clinically significant hypoglycaemia (low blood sugar levels)
- Women who are pregnant or breastfeeding
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00770302
Start Date
October 1 2008
End Date
October 1 2008
Last Update
July 9 2009
Active Locations (1)
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1
Research Site
Beijing, China