Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects
Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects
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
Inclusion criteria:

 -  Healthy male/female subjects,

 -  age of 18 to 55 years,

 -  body mass index (BMI) of 18.5 to 29.9 kg/m2

 -  Signed and dated written informed consent prior to admission to the study in
 accordance with GCP and local legislation

 -  Male subjects, or female subjects who meet any of the following criteria starting from
 at least 30 days before the first administration of trial medication and until 30 days
 after trial completion:

 -  Use of adequate contraception, e.g. any of the following methods plus condom:

 intrauterine device (non-hormonal)

 -  Sexually abstinent

 -  A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)

 -  Surgically sterilised (including hysterectomy)

 -  Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable
 cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below
 30 ng/L is confirmatory)

 Exclusion criteria:

 -  Any finding in the medical examination (including BP, PR or ECG) is deviating from
 normal and judged as clinically relevant by the investigator

 -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
 diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
 range of 60 to 90 bpm

 -  Any laboratory value outside the reference range that the investigator considers to be
 of clinical relevance

 -  Any evidence of a concomitant disease judged as clinically relevant by the
 investigator

 -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
 immunological or hormonal disorders

 -  Surgery of the gastrointestinal tract that could interfere with kinetics of the trial
 medication (except appendectomy and simple hernia repair)

 -  Diseases of the central nervous system (including but not limited to any kind of
 seizures or stroke), and other relevant neurological or psychiatric disorders

 -  History of relevant orthostatic hypotension, fainting spells, or blackouts

 -  Chronic or relevant acute infections

 -  History of relevant allergy or hypersensitivity (including allergy to the trial
 medication or its excipients)

 -  Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10
 half-lives of the respective drug prior to administration of trial medication

 -  Within 10 days prior to administration of trial medication, use of drugs that might
 reasonably influence the results of the trial or that might prolong the QT/QTc
 interval

 -  Participation in another trial where an investigational drug has been administered
 within 60 days prior to planned administration of trial medication

 -  Smoker

 -  Alcohol abuse Further exclusion criteria apply