Safety, Tolerability and Pharmacokinetics After Administration of Increasing Dose of BIBN 4096 BS in Healthy Male and Female Volunteers

Inclusion Criteria: * Participants should be healthy males and females * Age range from 21 to 50 years * Body Mass Index (BMI) is to be within 18.5 to 29.9 kg/m² (BMI calculation: weight in kilograms divided by the square of height in meters) * In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study * As part of the screening (within 14 days before drug administration), each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG) and a rhinomanometry (in order to familiarize the subject with this method; screening rhinomanometric values were not to be reported). Moreover laboratory parameters (including drug screening, HBs- antigen (HBs-Ag), anti Hepatitis B core (HBc) - antibodies, anti Hepatitis C Virus (HCV) - antibodies and Human immunodeficiency virus (HIV) test as well as pregnancy test for female subjects are to be determined. Exclusion Criteria: * Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders * History of orthostatic hypotension, fainting spells or blackouts * Chronic or relevant acute infections * History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * Intake of a drug with a long half-life (\> 24 hours) within at least 1 month or less than ten half-lives of the respective drug before enrolment in the study (except substitution therapy regarding thyroid gland/or ovaries) * Use of any drugs which might influence the results of the trial within 1 week prior to administration or during the trial * Participation in another study with an investigational drug within two months prior to administration or during the trial * Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * Inability to refrain from smoking on study days * Alcohol abuse (\> 60g/day) * Drug abuse * Blood donation (\>= 100 ml) within four weeks prior to administration or during the trial * Excessive physical activities within the last week before the study * Any laboratory value outside the reference range of clinical relevance For female subjects: * Pregnancy * Positive pregnancy test * No adequate contraception e.g. oral contraceptives, sterilization, intrauterine pessary (IUP) * Inability to maintain this adequate contraception during the whole study period * Lactation period