| Trial ID: | L3591 |
| Source ID: | NCT00935467
|
| Associated Drug: |
Saxagliptin
|
| Title: |
Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Saxagliptin
|
| Outcome Measures: |
Primary: Evidence of steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects, Within the first 24 hours of dosing | Secondary: To characterize the steady-state pharmacodynamics of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects, 18 time points up to 14 hours on two separate study days|To assess the PK of the pharmacologically active major metabolite of saxagliptin, BMS-510849, following administration of 2.5 mg saxagliptin twice daily with meals to healthy subjects, 21 time points up to 23 hours after first dosing|To assess the safety and tolerability of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects, Day 1 to Day 7
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
|
| Start Date: |
2009-07
|
| Completion Date: |
2009-08
|
| Results First Posted: |
|
| Last Update Posted: |
2015-05-05
|
| Locations: |
Ppd Development, Lp, Austin, Texas, 78744, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00935467
|
