Overview

Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Ipratropium
Tiotropium Bromide
Criteria
Inclusion Criteria:

All participants in the study should be healthy males, ranging from 40 to 65 years of age
and within ±20% of their normal weight (Broca-Index)

Each subject will have his medical history taken and will receive a complete medical
examination (including blood pressure and pulse rate measurements) as well as a 12-lead
ECG.

Haematological, hepatic and renal function tests will be carried out in the laboratory
(Bioscentia GmbH, FRG). The subjects will fast for 8 hours before collection of specimens
for all laboratory evaluations. The above mentioned examinations will be performed within
14 days before the first drug administration.

In accordance with Good Clinical Practice (GCP) and local legislation all subjects will
have given their written informed consent prior to admission to the study.

Following inclusion criteria were of special interest for this study:

- Normal spirometry as evidenced by a baseline FEV1 ≥ 80% of predicted normal value for
age, height and sex. Predicted normal values will be calculated according to European
Community of Coal and Steel (ECCS)

- Ability to perform technically satisfactory pulmonary function tests.

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 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 drugs with a long half-life (≥ 24hours) within at least one month or less
than ten half-lives of the respective drug before enrolment in the study or during the
study.

- Use of any drugs which might influence the results of the trial up to seven days prior
to enrolment in the study or during the study, among these all non-selective beta
blockers, oral beta adrenergics or long-acting beta-adrenergics such as salmeterol and
formoterol, and anticholinergic drugs including ATROVENT ®(ipratropium) by oral
inhalation and ATROVENT® Nasal Spray.

- Participation in another trial with an investigational drug (≤ two months prior to
administration or during trial).

- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)

- Inability to refrain from smoking on trial days.

- Alcohol abuse (> 60g/day)

- Drug abuse

- Blood donation (≥ 100 ml within four weeks prior to administration or during the
trial)

- Any laboratory value outside the clinically accepted reference range.

- Excessive physical activities (within the last week before and during the study)

Following exclusion criteria are of special interest for the study:

- Subjects with known hypersensitivity to anticholinergic drugs.

- Subjects with known symptomatic prostatic hypertrophy or bladder neck obstruction

- Subjects with known narrow-angle glaucoma