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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The pharmacokinetics study aims to evaluate the safety of Z7200 (budesonide/formoterol) in comparison with Symbicort Turbohaler (budesonide/formoterol), assessing the bioequivalence of the two products. Namely the study will compare the total systemic bioavailability (as an indicator of safety), and it will compare the pulmonary bioavailability (as a possible surrogate indicator of efficacy). This study will be performed in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zambon SpA
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Charcoal; Formoterol Fumarate

Criteria

Main Inclusion Criteria:

• Male or female 18 to 45 years of age.

• If female, is currently not pregnant/breast feeding/ or attempting to become pregnant has a negative serum pregnancy test, or is of non-childbearing potential or is of child-bearing potential, willing to commit to using a consistent and acceptable method of birth control or is of child-bearing potential and not sexually active

• Body mass index (BMI) of 18.5 to 29.9 kg/m² inclusive and a body weight ≥50 kg.

Main 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.