Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin
Phase 1
Completed
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT00770302
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin Multiple timepoints during 9 days
- Secondary Outcome Measures
Name Time Method Pharmacokinetic variables for saxagliptin's active metabolite BMS-510849 after single and multiple oral doses of 5 mg saxagliptin Multiple time points during 9 days 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 Multiple time points during 10 days (including measurements before dosing)
Trial Locations
- Locations (1)
Research Site
🇨🇳Beijing, China