| Eligibility |
Inclusion Criteria:
- Healthy male or female subjects according to the assessment of the investigator, as
based on a complete medical history including a physical examination, standardized
mental and neurological assessment, vital signs (blood pressure (BP), pulse rate
(PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests without
clinically significant abnormalities
- Age of 18 to 55 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with International Council for
Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to
admission to the trial
- Either male subjects or female subjects who meet the following criteria requiring
highly effective contraception from at least 30 days before the first administration
of trial medication until 30 days after trial completion:
- Use of adequate contraception, i.e. use of condom (male subjects or male partners
of female subjects) plus any of the following methods (female subjects or female
partners of male subjects): intrauterine device, hormonal contraception (e.g.
implants, injectables, combined oral or vaginal contraceptives), , surgically
sterilised (including bilateral tubal occlusion/ligation, hysterectomy, bilateral
oophorectomy) or postmenopausal, defined as no menses for 1 year without an
alternative medical cause (in questionable cases a blood sample with levels of
Follicle stimulating hormone (FSH) above 40 U/L is confirmatory)
- Sexually abstinent (considered a highly effective method only if defined as
refraining from heterosexual intercourse during the entire period of risk
associated with the study treatments)
- Vasectomised male subjects or male partners of female subjects (vasectomy at
least 1 year prior to enrolment) in combination with a barrier method (i.e. use
of condom) and provided that the partner is the sole sexual partner of the trial
participant Unprotected sexual intercourse (i.e. without use of condom) of a male
subject with a pregnant female partner and sperm donation is not allowed
throughout the study and until 30 days after trial completion. Female subjects
should not participate in egg donation from the first trial medication
administration, for the duration of the study and for at least 30 days after
trial completion.
Exclusion Criteria:
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal
and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140
millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to
90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
- Any laboratory value outside the reference range that the investigator considers to be
of clinical relevance, in particular hepatic parameters (alanine aminotransferase
(ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters
(creatinine) exceeding the Upper limit of normal (ULN) after repeated measurements
- Any evidence of a concomitant disease assessed as clinically relevant by the
investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere
with the pharmacokinetics of the trial medication (except appendectomy or simple
hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of
seizures or stroke, bulimia or anorexia, or bipolar mood disorder), and other relevant
neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts Further
exclusion criteria apply.
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