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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Desipramine tablet (Drug); Crobenetine infusion (Drug); Placebo infusion (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

To assess the steady state pharmacokinetics of Desipramine with/without concomitant administration of Crobenetine.

Clinical Details

Official title: Pharmacokinetics of 50 mg Desipramine Daily, Given Orally Over 7 Days With and Without Concomitant Administration of 175 mg Crobenetine, Given as a 6 Hrs i.v. Infusion (One Hour Loading Dose Directly Followed by a Five Hours Maintenance Dose). A Randomized, Placebo Controlled, Single Blind (for Crobenetine), Two-way Cross Over Trial in Healthy Male Subjects

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome:

Area under the concentration time curve for desipramine at steady state (AUC,ss)

Maximum plasma concentration of desipramine at steady state (Cmax,ss)

Secondary outcome:

Individual time courses of plasma concentrations

Area under the concentration time curve from zero time to time of last quantifiable drug concentration (AUC0-tz)

Area under the concentration time curve from zero time extrapolated to infinity(AUC0-infinity)

Time to reach maximum concentration of desipramine at steady state (tmax,ss)

Apparent terminal rate constant (λz)

Apparent terminal half-live in plasma (t1/2)

Mean residence time (MRT)

Total clearance (CL)

Apparent volume of distribution (V)

Observed concentration of crobenetine (C,h)

Number of subjects with adverse events

Number of subjects with clinically significant findings in vital signs

Number of subjects with clinically significant findings in 12-lead ECG

Number of subjects with clinically significant findings in laboratory tests

Eligibility

Minimum age: 21 Years. Maximum age: 50 Years. Gender(s): Male.

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)

Locations and Contacts

Additional Information

Starting date: February 2002
Last updated: October 23, 2014

Page last updated: August 23, 2015

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