Tolerability of Asasantin in Healthy Female and Male Subjects

Launched by BOEHRINGER INGELHEIM · Oct 20, 2014

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All participants in the study should be healthy females/males, range from 18 to 55 years of age and be within a Broca Index of ≥ - 20 % and ≤ + 20 %
• • Prior to admission to the study all subjects will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent.
• Exclusion Criteria:
• • Subjects will be excluded from the study if the results of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and are of clinical relevance
• • Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• • Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
• • Subjects with known history of orthostatic hypotension, fainting spells or blackouts
• • Subjects with chronic or relevant acute infections
• • Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• • Subjects who have taken a drug with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial)
• • Subjects who received any other drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
• • Subjects who have participated in another study with an investigational drug (≤ 1 month prior to administration or during the trial)
• • Subjects who smoke more than 15 cigarettes or 4 cigars or 4 pipes/day
• • Subjects who are not able to refrain from excessive consumption of methylxanthine containing drinks or food
• • Subjects who drink more than 60 g of alcohol per day
• • Subjects who are dependent on drugs
• • Subjects who have donated blood (\> 400 ml) (≤ 4 weeks prior to administration or during the trial)
• • Subjects who have participated in excessive physical activities (≤ 5 days prior to administration or during the trial)
• For female subjects:
• • Pregnancy
• • Positive pregnancy test
• • No adequate contraception (acceptable: e.g. sterilisation, intrauterine devices (IUD), oral contraceptives, condoms)
• • Inability to maintain this adequate contraception during the whole study period
• • Lactation period