Pharmacokinetics of Midazolam, With and Without Concomitant Administration of Crobenetine in Healthy Male Subjects

Overview

To assess the pharmacokinetics of midazolam with/without concomitant administration of crobenetine

Full Title of Study: “Pharmacokinetics of 7.5 mg Midazolam, Given Orally 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 Randomised, Single Blind, Two-way Crossover Trial in Healthy Male Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Primary Purpose: Treatment
    • Masking: Single
  • Study Primary Completion Date: April 2002

Interventions

  • Drug: Midazolam, tablet
  • Drug: Crobenetine, i.v. infusion
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: Midazolam and crobenetine
  • Placebo Comparator: Midazolam and placebo

Clinical Trial Outcome Measures

Primary Measures

  • Area under the concentration-time curve of midazolam from zero time extrapolated to infinity (AUC0-infinity)
    • Time Frame: up to 24 hours after start of drug administration
  • Maximum observed concentration of midazolam in plasma (Cmax)
    • Time Frame: up to 24 hours after start of drug administration

Secondary Measures

  • Area under the concentration-time curve (AUC)
    • Time Frame: up to 24 hours after start of drug administration
  • Time to maximum observed concentration (tmax)
    • Time Frame: up to 24 hours after start of drug administration
  • Individual time courses of plasma concentrations
    • Time Frame: up to 24 hours after start of drug administration
  • Terminal rate constant in plasma (λz)
    • Time Frame: up to 24 hours after start of drug administration
  • Terminal half-life in plasma (t1/2)
    • Time Frame: up to 24 hours after start of drug administration
  • Mean residence time in the body (MRT)
    • Time Frame: up to 24 hours after start of drug administration
  • Apparent clearance in plasma (CL/F)
    • Time Frame: up to 24 hours after start of drug administration
  • Volume of distribution (V)
    • Time Frame: up to 24 hours after start of drug administration
  • Changes from baseline in physical examination
    • Time Frame: pre-dose and day 8 after drug administration
  • Number of patients with clinically relevant findings in vital signs
    • Time Frame: up to day 8 after drug administration
    • blood pressure, pulse rate
  • Number of patients with clinically relevant findings in 12-lead ECG
    • Time Frame: up to day 8 after drug administration
  • Number of patients with clinically relevant findings in laboratory tests
    • Time Frame: up to day 8 after drug administration
  • Number of patients with adverse events
    • Time Frame: up to day 8 after drug administration
  • Global assessment of tolerability by the investigator on a 4-point rating scale
    • Time Frame: up to 192 hours after start of drug administration

Participating in This Clinical Trial

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

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 (except substitution therapy regarding thyroid gland)
  • Use of any drugs that 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

Gender Eligibility: Male

Minimum Age: 21 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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