Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.
2 other identifiers
interventional
18
1 country
1
Brief Summary
Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.
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
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
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 11, 2011
CompletedFirst Posted
Study publicly available on registry
October 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedResults Posted
Study results publicly available
June 27, 2014
CompletedJune 27, 2014
June 1, 2014
1 month
October 11, 2011
May 16, 2014
June 26, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 hours extrapolated to infinity (AUC0-∞). The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.
1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagloflozin (empa) in plasma, per period. The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.
1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Secondary Outcomes (1)
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator.
Screening until end of trial, average of 45 days
Study Arms (3)
Treatment A
EXPERIMENTALhigh dose of empagliflozin after overnight fasting for at least 10 h
Treatment B
EXPERIMENTALhigh dose of empagliflozin after a standardised high fat breakfast
Treatment C
EXPERIMENTALlow dose empagliflozin after overnight fasting for at least 10 h
Interventions
Eligibility Criteria
You may qualify if:
- \. Healthy male and female subjects
You may not qualify if:
- \. Any relevant deviation from healthy conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1245.79.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
MeSH Terms
Interventions
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2011
First Posted
October 14, 2011
Study Start
October 1, 2011
Primary Completion
November 1, 2011
Last Updated
June 27, 2014
Results First Posted
June 27, 2014
Record last verified: 2014-06