Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects - ULDS
Study identifier:MB102-088
ClinicalTrials.gov identifier:NCT01135446
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
Medical condition
Type 2 Diabetes
Phase
Phase 1
Healthy volunteers
Yes
Study drug
dapagliflozin
Sex
All
Actual Enrollment
35
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 May 2010
Primary Completion Date: 01 Jun 2010
Study Completion Date: 01 Jun 2010
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Oct 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: dapagliflozin (0.001 mg) Cohort 1 | Drug: dapagliflozin Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days Other Name: BMS-512148 |
| Experimental: dapagliflozin (0.01 mg) Cohort 2 | Drug: dapagliflozin Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days Other Name: BMS-512148 |
| Experimental: dapagliflozin (0.1 mg) Cohort 3 | Drug: dapagliflozin Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days Other Name: BMS-512148 |
| Experimental: dapagliflozin (0.3 mg) Cohort 4 | Drug: dapagliflozin Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days Other Name: BMS-512148 |
| Experimental: dapagliflozin (1 mg) Cohort 5 | Drug: dapagliflozin Tablets, Oral, 1 mg, once on Day 1 only, 2 days Other Name: BMS-512148 |
| Experimental: dapagliflozin (2.5 mg) Cohort 6 | Drug: dapagliflozin Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days Other Name: BMS-512148 |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
