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Inclusion criteria
Exclusion criteria
Lack of suitability for the trial
Any evidence of a significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrinological, metabolic (acidosis), psychiatric or other disease at screening
History of malignancy
Any clinically relevant deviation in clinical or laboratory assessment
Clinically relevant abnormalities in the 12-lead ECG which in the discretion of the investigator and the Merz scientific expert might affect the study objectives
Systolic blood pressure <95 mmHg or >150 mmHg or diastolic blood pressure < 50 mmHg or >90 mmHg in supine position
Pulse rate <45 or >100 beats per minute
Clinically relevant chronic or acute infections
Acute or chronic disease, especially psychiatric or neurologic disorders
Current evidence of hypokalemia (= below lower limit of laboratory normal range plus 0.3 mmol/l as safety margin)
History of alcohol or drug dependence within the last 2 years
Alcohol consumption averaging more than 40 g for male and more than 20 g for female subject daily within the last year
Regular caffeine consumption averaging more than 1 L of coffee and/or tea daily or more than 1 L of caffeine-containing lemonades per day within the last year
Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal products (e.g. acute inflammations, gastrointestinal disease, cholecystectomy, resection of small or large intestine, etc.)
Use of any prescribed medication for four weeks prior to the first administration of IMP.
Use of any food, food supplement or medication known to induce or inhibit CYP3A4 or other cytochrome P450 enzymes within two weeks preceding the start of the study (Day 1), e.g. grapefruit, St. John's wort
Special diet, e.g. vegetarian
Female subject who employed any form of hormonal contraception within 2 months prior to Day 1 (e.g. oral contraceptives, hormone releasing intrauterine contraceptive devices [IUDs], etc.)
Consume of xanthine derivates (including caffeine) within two days prior to Day 1
Smoker and user of snuff, nicotine replacement and chewing tobacco
Previous enrolment into the clinical phase of the current study
Positive results in any of the serology tests
Blood donation of more than 450 mL within 60 days prior to Day 1
Positive pregnancy test, if female
Positive drug screen or alcohol test
Administrative reasons
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Data sourced from clinicaltrials.gov
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