Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.

Study Overview
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Brief Summary
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The purpose of the study is to compare the pharmacokinetics of nebulized amikacin administered with three vibrating mesh nebulizers coupled with a single limb circuit bilevel ventilator in healthy volunteers. Following our previous in vitro study, our hypotheses are that the pharmacokinetics varies among the devices tested and that a most efficient device can be identified.

Official Title
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Comparison of Pharmacokinetics of Amikacin Administered by Three Vibrating Mesh Nebulizers in Healthy Volunteers

Conditions
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Acute Respiratory Insufficiency, Chronic Respiratory Insufficiency, Bronchospasm and Obstruction

Intervention / Treatment
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* Device: Nebulizer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No contraindication of amikacin Written informed consent Negative pregnant test (for women) Exclusion Criteria: History of respiratory disease History of renal disease History of otological disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solo nebulizer<br>Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Solo nebulizer associated with a bilevel ventilator | Device: Nebulizer<br>* 500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds.<br>* Other names: Vibrating-mesh nebulizers;|
| Experimental: Pro nebulizer<br>Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Pro nebulizer associated with a bilevel ventilator | Device: Nebulizer<br>* 500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds.<br>* Other names: Vibrating-mesh nebulizers;|
| Experimental: NIVO nebulizer<br>Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb NIVO nebulizer associated with a bilevel ventilator | Device: Nebulizer<br>* 500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds.<br>* Other names: Vibrating-mesh nebulizers;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of nebulized amikacin | The area under the urinary amikacin concentration-time curve after nebulization(AUC0-24 hour) is calculated from the data obtained during 24 hours after nebulization. To determine amikacin absorption during the nebulization, amikacin concentrations are measured in the 24 hours urine collections, which reflected the quantity of dose absorbed via inhalation. | within the first 24 hours after nebulization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non invasive ventilation, single limb circuit ventilator, bilevel, nebulization, nebulizer, vibrating mesh nebulizer, amikacin