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.

• ClinicalTrials.gov Identifier: NCT01451775
• Recruitment Status: Completed
• First Posted: October 14, 2011
• Results First Posted: June 27, 2014
• Last Update Posted: June 27, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: October 11, 2011
• First Posted Date: October 14, 2011
• Results First Submitted Date: May 16, 2014
• Results First Posted Date: June 27, 2014
• Last Update Posted Date: June 27, 2014
• Study Start Date: October 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 26, 2014)

• Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 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 ]
  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.
• Maximum Measured Concentration (Cmax) [ Time Frame: 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 of empagloflozin (empa) in plasma, per period. The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.

Original Primary Outcome Measures (submitted: October 11, 2011)

• area under the concentration time curve of empagliflozin in plasma over time interval from 0 hours extrapolated to infinity (AUC0-8) [ Time Frame: 72 hours ]
• maximum measured concentration of empagliflozin in plasma (Cmax) [ Time Frame: 72 hours ]

Current Secondary Outcome Measures (submitted: June 26, 2014)

Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator. [ Time Frame: Screening until end of trial, average of 45 days ]

Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• Official Title: Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet and Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets in an Open, Randomised, Single Dose, Three-period Cross-over Study in Healthy Male and Female Subjects
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

• Drug: Empagliflozin
  high dose of empagliflozin after overnight fasting for at least 10 h
• Drug: Empagliflozin
  low dose empagliflozin after overnight fasting for at least 10 h
• Drug: Empagliflozin
  high dose of empagliflozin after a standardised high fat breakfast

Study Arms

• Experimental: Treatment A
  high dose of empagliflozin after overnight fasting for at least 10 h
  Intervention: Drug: Empagliflozin
• Experimental: Treatment B
  high dose of empagliflozin after a standardised high fat breakfast
  Intervention: Drug: Empagliflozin
• Experimental: Treatment C
  low dose empagliflozin after overnight fasting for at least 10 h
  Intervention: Drug: Empagliflozin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 11, 2011): 18
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01451775
• Other Study ID Numbers: 1245.79; 2011-002836-13 ( EudraCT Number: EudraCT )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Boehringer Ingelheim
• Study Sponsor: Boehringer Ingelheim
• Collaborators: Not Provided

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

• PRS Account: Boehringer Ingelheim
• Verification Date: June 2014