A Clinical Study to Evaluate Z7200 (Budesonide/Formoterol) Pharmacokinetics Profile in Healthy Volunteers

Exclusion Criteria

• •FEV1 value less than 80% of the predicted value and FEV1/FVC ratio \<0.7.
• •History or current evidence of a clinically significant disease or disorder capable of altering the absorption, metabolism, distribution or elimination of drugs.
• •History or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, haematological, neuropsychological, endocrine, gastrointestinal or pulmonary.
• •Presence of glaucoma, cataracts, ocular herpes simplex, malignancy, regardless of the clinical significance or current stability of the disease.
• •History or presence of silent infections, including positive tests for HIV1, HIV2, Hepatitis B and Hepatitis C.
• •Bacterial or viral infection of the upper respiratory tract (including the common cold and flu), sinus, or middle ear within 2 weeks of dosing.
• •Lower respiratory tract infection/pneumonia within the past 3 months.
• •Presence of any disease or condition or regular concomitant treatment (including vitamins and herbal products) known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• •Screening haemoglobin value of less than 1g/dL above the ULN (or 10g/L)
• •History of recurrent vasovagal collapses.
• •History of anaphylactic/anaphylactoid reactions.
• •History of seizures including febrile seizures excluding childhood febrile convulsions.
• •Unable to demonstrate proper inhalation techniques involved in using the delivery devices at screening.
• •Exposure to any investigational drug within 90 days of the Screening Visit.
• •Known or suspected hypersensitivity or idiosyncratic reaction to any steroid, any β2 agonist,or to lactose monohydrate, leucine or Tween 80.
• •History of allergy to milk protein.
• •Use of an inhaled corticosteroid within 30 days or systemic corticosteroid within 60 days of the Screening Visit.
• •Use of medications or herbal medicines that are strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 30 days prior to Screening Visit
• •Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
• •Use of caffeine containing beverages more than 600 mg of caffeine/day.
• •Current smokers or ex-smokers who have stopped smoking for less than 10 years.
• •Recent or current (suspected) drug abuse or positive result in the drugs abuse test.
• •Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 14 units per week for females \[1 unit = 4 cl spirits or equivalent\]).
• •Predictable poor compliance, intolerance to charcoal solution, or inability to communicate well with the study centre personnel or inability to participate in all treatment periods.
• •The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions, has participated in a clinical research study within the previous three months or has previously been enrolled in this study.