A study to to assess the effect of dapagliflozin when administered once a day versus twice a day on blood glucose
Study identifier:D1691C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An open-label, randomised, two-period crossover study to assess the effect of dapagliflozin on percent inhibition of glucose re-absorption when administered once a day (10 mg OD) versus twice a day (5 mg BID) in healthy male and female volunteers
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Dapagliflozin
Sex
All
Actual Enrollment
16
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Feb 2010
Primary Completion Date: 01 Apr 2010
Study Completion Date: 01 Apr 2010
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: Dapagliflozin Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg) Drug: Dapagliflozin Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days |
| Experimental: 2 | Drug: Dapagliflozin Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg) Drug: Dapagliflozin Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days |
Contacts
Investigators
Principal Investigator
Georg Golor
PAREXEL International GmbH
