Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Spray Dried BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers

Inclusion Criteria:

Subjects could be included in the study if they met the following criteria:

• Healthy male or female volunteers
• Written informed consent in accordance with Good Clinical Practice (GCP) and the local legislation prior to admission to the study
• Age 21 - 50 years
• Body mass index (BMI): 18.5 - 29.9 kg/m2

Exclusion Criteria:

Subjects were not allowed to participate if any of the following applied:

• Any finding of the medical examination (including blood pressure, pulse rate, Respiratory rate, body temperature and ECG) deviating from normal and of clinical relevance
• Raw > 3 cm H2O • s • L-1 or FEV1 <80% of predicted
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system, psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts,
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug before enrolment in the study
• Use of any drugs which might influence the results of the trial (within 1 week prior to administration of investigational drug or during the trial)
• Participation in another trial with an investigational drug (within 2 months prior to drug administration or during the trial)
• Smoker (>10 cigarettes/day or >3 cigars/day or >3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (>60 gram/day)
• Drug abuse
• Blood donation (≥100 mL within 4 weeks prior to administration of investigational drug or during the trial)
• Excessive physical activities (within the last week before the study)
• Any laboratory value outside the reference range and of clinical relevance

• For female subjects:

  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device
  • Inability to maintain this adequate contraception during the whole study period,
  • Lactation period