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Trial record 12 of 47 for:    DESIPRAMINE

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

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ClinicalTrials.gov Identifier: NCT02273466
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Desipramine tablet Drug: Crobenetine infusion Drug: Placebo infusion Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
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 Start Date : February 2002
Actual Primary Completion Date : April 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Desipramine alone Drug: Desipramine tablet
Drug: Placebo infusion
Experimental: Desipramine with Crobenetine Drug: Desipramine tablet
Drug: Crobenetine infusion



Primary Outcome Measures :
  1. Area under the concentration time curve for desipramine at steady state (AUC,ss) [ Time Frame: up to 168 hours after start of drug administration ]
  2. Maximum plasma concentration of desipramine at steady state (Cmax,ss) [ Time Frame: up to 168 hours after start of drug administration ]

Secondary Outcome Measures :
  1. Individual time courses of plasma concentrations [ Time Frame: up to 168 hours after start of drug administration ]
  2. Area under the concentration time curve from zero time to time of last quantifiable drug concentration (AUC0-tz) [ Time Frame: up to 168 hours after start of drug administration ]
  3. Area under the concentration time curve from zero time extrapolated to infinity(AUC0-infinity) [ Time Frame: up to 168 hours after start of drug administration ]
  4. Time to reach maximum concentration of desipramine at steady state (tmax,ss) [ Time Frame: up to 168 hours after start of drug administration ]
  5. Apparent terminal rate constant (λz) [ Time Frame: up to 168 hours after start of drug administration ]
  6. Apparent terminal half-live in plasma (t1/2) [ Time Frame: up to 168 hours after start of drug administration ]
  7. Mean residence time (MRT) [ Time Frame: up to 168 hours after start of drug administration ]
  8. Total clearance (CL) [ Time Frame: up to 168 hours after start of drug administration ]
  9. Apparent volume of distribution (V) [ Time Frame: up to 168 hours after start of drug administration ]
  10. Observed concentration of crobenetine (C,h) [ Time Frame: 1 and 6 hours after start of infusion ]
  11. Number of subjects with adverse events [ Time Frame: up to 8 days after last drug administration ]
  12. Number of subjects with clinically significant findings in vital signs [ Time Frame: up to 8 days after last drug administration ]
    blood pressure, pulse rate

  13. Number of subjects with clinically significant findings in 12-lead ECG [ Time Frame: up to 8 days after last drug administration ]
  14. Number of subjects with clinically significant findings in laboratory tests [ Time Frame: up to 8 days after last drug administration ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02273466     History of Changes
Other Study ID Numbers: 599.11
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Desipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs