Tolerability of a Two Week Treatment With Asasantin Extended Release 200/25 mg Capsules b.i.d., Compared to Reduced Dose During the First Week of Treatment in a Double-blind, Randomised, Placebo Controlled Parallel Group Comparison Trial in Healthy Female and Male Subjects

Date de début de l'étude : 1 février 2000

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