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Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01156246
First received: June 28, 2010
Last updated: May 31, 2012
Last verified: May 2012
History of Changes

June 28, 2010
May 31, 2012
June 2010
August 2010   (final data collection date for primary outcome measure)
To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin. [ Time Frame: Serial PK sampling will be done on Days 1-4 at visit 2 and 3. ] [ Designated as safety issue: No ]
primary - single dose Cmax, AUCinf, AUC(0-t) of dapagliflozin and metformin.. secondary - single dose tmax, t1/2 of dapagliflozin and metformin
Same as current
Complete list of historical versions of study NCT01156246 on ClinicalTrials.gov Archive Site
To examine the safety and tolerability of the fixed-dose combination tablet of dapagliflozin and metformin. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
Vital signs (blood pressure and heart rate), electrocardiogram, laboratory safety data (clinical chemistry, haematology and urinalysis), adverse events.
Same as current
Not Provided
Not Provided
 
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

The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Drug: Dapagliflozin/Metformin
oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3.
  • 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.
    Intervention: Drug: Dapagliflozin/Metformin
  • 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.
    Intervention: Drug: Dapagliflozin/Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy
  • BMI 18-30 kg/m2

Exclusion Criteria:

  • History of clinically significant illness.
  • History of alcohol or drug abuse
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01156246
D1691C00005
No
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
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
AstraZeneca
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP