Status:
COMPLETED
A Clinical Study to Evaluate Z7200 (Budesonide/Formoterol) Pharmacokinetics Profile in Healthy Volunteers
Lead Sponsor:
Zambon SpA
Conditions:
Asthma
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The primary objective was: \- to assess the bioequivalence of a single dose (two inhalations) of the test product compared to the reference product, with and without charcoal blockade. The secondary...
Detailed Description
This was a single center, open label, randomized, five-period crossover, single-dose study in healthy volunteers aged 18 to 45 years. A total of 90 volunteers were enrolled, with 9 subjects in each of...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02237508
Start Date
September 1 2014
End Date
February 1 2015
Last Update
February 23 2022
Active Locations (1)
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1
Quotient Clinical Ltd
Ruddington, United Kingdom, NG11 6JS