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

NCT02273466 | Completed Phase 1

• 1 other identifier: 599.11
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 168 hours after start of drug administration

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

  up to 168 hours after start of drug administration

Secondary Outcomes (14)

• Individual time courses of plasma concentrations

  up to 168 hours after start of drug administration

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

  up to 168 hours after start of drug administration

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

  up to 168 hours after start of drug administration

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

  up to 168 hours after start of drug administration

• Apparent terminal rate constant (λz)

  up to 168 hours after start of drug administration

Study Arms (2)

Desipramine alone

ACTIVE COMPARATOR

Drug: Desipramine tablet; Drug: Placebo infusion

Desipramine with Crobenetine

EXPERIMENTAL

Drug: Desipramine tablet; Drug: Crobenetine infusion

Interventions

Desipramine tablet DRUG

Desipramine alone; Desipramine with Crobenetine

Crobenetine infusion DRUG

Desipramine with Crobenetine

Placebo infusion DRUG

Desipramine alone

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Desipramine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 24, 2014
• Study Start: February 1, 2002
• Primary Completion: April 1, 2002
• Last Updated: October 24, 2014

Record last verified: 2014-10