Study to assess the effect of food on combination dapagliflozin/metformin tablet in healthy volunteers
Study identifier:D1691C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An open label, randomized, two-period, crossover study to assess the effect of food on fixed dose combination dapagliflozin/metformin tablet (5 mg/1000 mg) in healthy male and female volunteers
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Dapagliflozin/Metformin
Sex
All
Actual Enrollment
18
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Aug 2010
Study Completion Date: 01 Aug 2010
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Oct 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 Dapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, fasting conditions day 1, visit 3. | Drug: Dapagliflozin/Metformin oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3. |
| Experimental: 2 Dapagliflozin/metformin tablet, fasting conditions day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 3. | Drug: Dapagliflozin/Metformin oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3. |
Contacts
Investigators
Principal Investigator
Aslak Rautio
Quintiles Hermelinen AB, Varvsgatan 53, SE-972 33 Luleå, Sweden
