Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects. Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra nebulizer solution compared to TOBI nebulizer solution.

Official Title
-----------------
Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy Subjects

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Vantobra (tobramycin)
* Drug: TOBI (tobramycin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female healthy subjects of any ethnic origin Aged between 18 and 50 years of age Body weight of ≥50 kg and body mass index (BMI) between 18.5 and 29 kg/m2 FEV1 > 90% of predicted Able to demonstrate correct inhaler use Written informed consent Exclusion Criteria: History of clinically relevant allergies or idiosyncrasies to tobramycin or any other inactive ingredient(s) of the IMP Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis. Any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric or other diseases at screening Surgery of the gastrointestinal or respiratory tract which might interfere with drug absorption History of malignancy within the past 5 years History of orthostatic hypotension, faintings or blackouts Acute or chronic viral, bacterial or fungal airway infections, including laryngeal infections, mouth and throat infections, and hoarseness; Other clinically relevant chronic or acute infectious illnesses Clinical chemical, hematological or any other laboratory parameters clinically relevant outside the normal range

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vantobra; Treatment A<br>Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution | Drug: Vantobra (tobramycin)<br>* Inhalation<br>|
| Active Comparator: TOBI; Treatment B<br>TOBI, 300 mg tobramycin/5 mL nebulizer solution | Drug: TOBI (tobramycin)<br>* Inhalation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects | Plasma AUClast of tobramycin | Day 1 and Day 7 | 
| To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects | Plasma Cmax of tobramycin | Day 1 and Day 7 | 
| To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects | tmax of tobramycin | Day 1 and Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events during the trial period | Adverse events | Adverse Events during the study period of max. 17 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AUC, Bioequivalence, Cmax