Status:
COMPLETED
Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising of BEA 2180 BR in Japanese Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-35 years
Phase:
PHASE1
Brief Summary
Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese healthy volunteers
Eligibility Criteria
Inclusion
- Healthy Japanese men:
- According to the results of a complete medical history, the physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests
- Age ≥20 and ≤35 years
- Body mass index (BMI) ≥18.5 and ≤25 kg/m2
- Subjects must be able to inhale medication in a competent manner from the Respimat®
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP)
Exclusion
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity including allergy to drug or its excipients
- Intake of drugs with a long half-life (\>24 hours) within one month or less than 10 half-lives of the respective drug before drug administration or during the trial
- Use of prescription or non-prescription drugs within 10 days before drug Administration or during the trial. However, over-the-counter (OTC) drugs for external application (such as lubricant eye drops for contact lens, insect bite reliever) shall be allowed
- Participation in another trial with an investigational drug within four months before drug administration or during the trial
- Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
- Inability to refrain from smoking during the trial
- Alcohol abuse (≥60 g/day: corresponds to ca. 3 large bottles of beer, 3 gous (ca. 540 cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of Japanese shochu, distilled alcoholic beverage)
- Drug abuse
- Blood donation (≥100 mL within four weeks before drug administration or during the trial)
- Excessive physical activities (within one week before drug administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- Exclusion criteria specific for this study:
- Occupational (professional) exposure to antimuscarinic substances (e.g., physician, nurse, pharmacist etc.; volunteers working for medical institutions, research institutions or herb gardens)
- History of glaucoma, urination difficulty (due to prostatic hyperplasia etc.)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02254109
Start Date
April 1 2008
Last Update
October 1 2014
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