Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01156246 |
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Recruitment Status
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Completed
First Posted
: July 2, 2010
Last Update Posted
: June 1, 2012
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Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | June 28, 2010 | |||||||||
| First Posted Date ICMJE | July 2, 2010 | |||||||||
| Last Update Posted Date | June 1, 2012 | |||||||||
| Study Start Date ICMJE | June 2010 | |||||||||
| Actual Primary Completion Date | August 2010 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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. ] primary - single dose Cmax, AUCinf, AUC(0-t) of dapagliflozin and metformin.. secondary - single dose tmax, t1/2 of dapagliflozin and metformin
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT01156246 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE |
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. ] Vital signs (blood pressure and heart rate), electrocardiogram, laboratory safety data (clinical chemistry, haematology and urinalysis), adverse events.
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers | |||||||||
| Official Title ICMJE | 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 | |||||||||
| Brief Summary | The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase | Phase 1 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy | |||||||||
| Intervention ICMJE | Drug: Dapagliflozin/Metformin
oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3. |
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| Study Arms |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
18 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Actual Study Completion Date | August 2010 | |||||||||
| Actual Primary Completion Date | August 2010 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 55 Years (Adult) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Sweden | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01156246 | |||||||||
| Other Study ID Numbers ICMJE | D1691C00005 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | AstraZeneca | |||||||||
| Study Sponsor ICMJE | AstraZeneca | |||||||||
| Collaborators ICMJE | Bristol-Myers Squibb | |||||||||
| Investigators ICMJE |
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| PRS Account | AstraZeneca | |||||||||
| Verification Date | May 2012 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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