Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)
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The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-metered-dose inhaler (MDI). The administration of the study medication will be as follows: three single doses, separated by a wash-out period. The study will provide further data on the safety and tolerability of ciclesonide.
A Randomized, Open-label, Single-dose, 3-period Crossover, Pharmacokinetic Study Designed to Compare the Systemic Des-ciclesonide Exposure of OMNARIS™ (Ciclesonide) Nasal Spray, Ciclesonide HFA Nasal Aerosol, and Orally Inhaled Ciclesonide
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main Inclusion Criteria:
Written informed consent and HIPAA
Body weight as indicate by a Body Mass Index (BMI) between ≥ 18 and ≤ 28 kg/m², and a body weight >50 kg
General good health
Ability to use oral inhaler
Main Exclusion Criteria:
Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
Participation in any investigational drug trial within the 30 days before Screening Visit and thereafter
History or current clinically relevant allergies or idiosyncrasy to drugs or food
History of allergic reactions to any corticosteroids including ciclesonide or any excipients of the formulations
Any contraindication to nasally administered corticosteroids
History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)] within the 30 days before Screening Visit, or development of a respiratory infection during the Screening Period
History or current evidence of any other relevant allergic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, neurological, psychiatric, or other disease within the last 2 years
Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding Screening Visit