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.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Empagliflozin

• Registration Number: NCT01451775
• Lead Sponsor: Boehringer Ingelheim

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 available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-14
• Primary Completion: 2011-11
• Results First Submitted: 2014-05-16
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-26
• Last Update Submitted: 2014-06-26
• Results First Posted: 2014-06-27
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B	Empagliflozin	high dose of empagliflozin after a standardised high fat breakfast
Treatment A	Empagliflozin	high dose of empagliflozin after overnight fasting for at least 10 h
Treatment C	Empagliflozin	low dose empagliflozin after overnight fasting for at least 10 h

Primary Outcome Measures

Name	Time	Method
Maximum Measured Concentration (Cmax)	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.
Area Under the Curve 0 to Infinity (AUC0-∞)	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

1245.79.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany