| Trial ID: | L5036 |
| Source ID: | NCT00770302
|
| Associated Drug: |
Saxagliptin
|
| Title: |
Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Saxagliptin
|
| Outcome Measures: |
Primary: Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin, Multiple timepoints during 9 days | Secondary: 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)
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
34
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2008-10
|
| Completion Date: |
2008-10
|
| Results First Posted: |
|
| Last Update Posted: |
2009-07-09
|
| Locations: |
Research Site, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT00770302
|
