Clinical trial NCT01276301: DDI Between BI Empagliflozin (10773) and Verapamil
Official title: Relative Bioavailability of BI 10773 Given Alone and Together With Verapamil - an Open-label, Randomised, Crossover Trial in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Relative bioavailability of BI 10773 given alone and together with verapamil


Eligibility criteria: Inclusion criteria:

healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions

Primary outcomes:
measure: Area Under the Curve 0 to Infinity (AUC0-∞)
timeFrame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
measure: Maximum Measured Concentration (Cmax)
timeFrame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Secondary outcomes:
measure: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
timeFrame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
measure: Time From 0 to Maximum Plasma Concentration (Tmax)
timeFrame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
measure: Terminal Elimination Rate Constant (λz)
timeFrame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
measure: Terminal Half-life in Plasma (t1/2)
timeFrame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
measure: Mean Residence Time in the Body After Administration (MRTpo)
timeFrame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
measure: Apparent Clearance in Plasma After Extravascular Administration (CL/F)
timeFrame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
measure: Apparent Volume of Distribution Following an Extravascular Dose (Vz/F)
timeFrame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
measure: Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).
timeFrame: Day1 to Day 11
measure: Assessment of Tolerability by Investigator
timeFrame: Within Day 15 to Day 25
Other outcomes:
measure: Verapamil Plasma Concentration
timeFrame: Predose and 1 hour (h), 25h, 49h and 73h after verapamil administration
Locations:
city: Biberach
country: Germany
facility: 1245.43.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Macha S, Sennewald R, Rose P, Schoene K, Pinnetti S, Woerle HJ, Broedl UC. Lack of clinically relevant drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and verapamil, ramipril, or digoxin in healthy volunteers. Clin Ther. 2013 Mar;35(3):226-35. doi: 10.1016/j.clinthera.2013.02.015.