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

NCT02269202 | Completed Phase 1

• 1 other identifier: 599.12
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 24 hours after start of drug administration

• Maximum observed concentration of midazolam in plasma (Cmax)

  up to 24 hours after start of drug administration

Secondary Outcomes (14)

• Area under the concentration-time curve (AUC)

  up to 24 hours after start of drug administration

• Time to maximum observed concentration (tmax)

  up to 24 hours after start of drug administration

• Individual time courses of plasma concentrations

  up to 24 hours after start of drug administration

• Terminal rate constant in plasma (λz)

  up to 24 hours after start of drug administration

• Terminal half-life in plasma (t1/2)

  up to 24 hours after start of drug administration

Study Arms (2)

Midazolam and crobenetine

EXPERIMENTAL

Drug: Midazolam, tablet; Drug: Crobenetine, i.v. infusion

Midazolam and placebo

PLACEBO COMPARATOR

Drug: Midazolam, tablet; Drug: Placebo

Interventions

Midazolam, tablet DRUG

Midazolam and crobenetine; Midazolam and placebo

Crobenetine, i.v. infusion DRUG

Midazolam and crobenetine

Placebo DRUG

Midazolam and placebo

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

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 (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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Midazolam; BIII 890 CL

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 21, 2014
• Study Start: February 1, 2002
• Primary Completion: April 1, 2002
• Last Updated: October 21, 2014

Record last verified: 2014-10