Overview

Pharmacokinetics of Oral Desipramine With and Without Concomitant Administration of Crobenetine Infusion in Healthy Male Subjects

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
To assess the steady state pharmacokinetics of Desipramine with/without concomitant administration of Crobenetine.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Desipramine
Criteria
Inclusion Criteria:

All participants in the study should be healthy males, range from 21 to 50 years of age and
their bodymass index (BMI) be within 18.5 to 29.9 kg/m2.

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

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 relevant 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 (> 24 hours) within at least one month or less
than ten half-lives of the respective drug before enrolment in the study

- Use of any drugs which might influence the results of the trial (within one week prior
to administration or during the trial)

- Participation in another trial 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 trial days

- Alcohol abuse (> 60 g/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

- Cytochrome P450 2D6 poor metaboliser (to be determined by phenotyping or genotyping)