Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT01953367
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01953367
Study Brief:
Protocol Section:
NCT01953367