Part I: To investigate whether and to what extent donepezil affects single dose pharmacokinetics of BI 409306 Part II: To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics of donepezil
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany
Part 1: AUC0-tz of BI 409306
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point.
Time frame: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours thereafter.
Part 1: Cmax of BI 409306
Maximum measured concentration of the BI 409306 in plasma.
Time frame: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter.
Part 2: AUC0-tz of Donepezil
Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point.
Time frame: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.
Part 2: Cmax of Donepezil
Maximum measured concentration of the donepezil in plasma.
Time frame: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.
Part 1: AUC 0-infinity of BI 409306
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity.
Time frame: At approximate 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter.
Part 2: AUC0-infinity of Donepezil
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This outcome measure presents the area under the concentration-time curve of donepezil in plasma over the time interval from 0 extrapolated to infinity.
Time frame: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.