Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Dapagliflozin/Metformin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Aslak Rautio, Principal Investigator, Affiliation: Quintiles Hermelinen AB, Varvsgatan 53, SE-972 33 Luleå, Sweden Wolfgang Kühn, Principal Investigator, Affiliation: Quintiles AB, Global Phase I Services, Strandbodgatan 1, SE-753 23 Uppsala, Sweden Mirjana Kujacic, Study Chair, Affiliation: AZ Global Clinical Development, Pepparedsleden 1, 431 83 Mölndal, 431 83 Mölndal
Summary
The purpose of this study is to determine whether treatment with a fixed dose combination
dapagliflozin/metformin tablet is affected by food.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin.
Secondary outcome: To examine the safety and tolerability of the fixed-dose combination tablet of dapagliflozin and metformin.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy
- BMI 18-30 kg/m2
Exclusion Criteria:
- History of clinically significant illness.
- History of alcohol or drug abuse
Locations and Contacts
Research Site, Lulea, Sweden
Additional Information
Starting date: June 2010
Last updated: May 31, 2012
|