Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers
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
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jun 2010
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 28, 2010
CompletedFirst Posted
Study publicly available on registry
July 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJune 1, 2012
May 1, 2012
2 months
June 28, 2010
May 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin.
primary - single dose Cmax, AUCinf, AUC(0-t) of dapagliflozin and metformin.. secondary - single dose tmax, t1/2 of dapagliflozin and metformin
Serial PK sampling will be done on Days 1-4 at visit 2 and 3.
Secondary Outcomes (1)
To examine the safety and tolerability of the fixed-dose combination tablet of dapagliflozin and metformin.
ECG at screening and follow-up. BP/pulse at screening, once daily during residential period and at follow-up. Clinical chemistry, haematology, and urine analyses at screening, day-1, day 4, and at follow-up.
Study Arms (2)
1
EXPERIMENTALDapagliflozin/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.
2
EXPERIMENTALDapagliflozin/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.
Interventions
oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3.
Eligibility Criteria
You may qualify if:
- Healthy
- BMI 18-30 kg/m2
You may not qualify if:
- History of clinically significant illness.
- History of alcohol or drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Research Site
Luleå, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aslak Rautio
Quintiles Hermelinen AB, Varvsgatan 53, SE-972 33 Luleå, Sweden
- PRINCIPAL INVESTIGATOR
Wolfgang Kühn
Quintiles AB, Global Phase I Services, Strandbodgatan 1, SE-753 23 Uppsala, Sweden
- STUDY CHAIR
Mirjana Kujacic
AZ Global Clinical Development, Pepparedsleden 1, 431 83 Mölndal, 431 83 Mölndal
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2010
First Posted
July 2, 2010
Study Start
June 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
June 1, 2012
Record last verified: 2012-05