Status:
COMPLETED
Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Due to the complexity of orally inhaled products (combination of a formulation and a device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo correlation(IVIVC) for inh...
Detailed Description
In order to reduce variability, a crossover design is chosen. An open study design is regarded appropriate because the study is a pilot and the primary study variables are pharmacokinetic(PK) paramete...
Eligibility Criteria
Inclusion
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history, and laboratory and physical examinations.
- Finnish speaking males and females, 18-60 (inclusive) years of age.
- Normal weight defined as body mass index (BMI) \> 19 and \< 30 kg/m2 (BMI = weight/height2)
- Weight at least 50 kg
- Hemoglobin 135-195 g/l male, 125-175 g/l female.
Exclusion
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
- Intake of any medication that could affect the outcome of the study. As an exception, contraceptives and hormone replacement therapy are allowed.
- Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram \[ECG\] and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator.
- Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
- History of vasovagal collapses.
- History of anaphylactic/anaphylactoid reactions.
- History of seizures including febrile seizures.
- Pregnant or lactating females.
- Females of childbearing potential not using proper contraception (mechanical and/or hormonal contraception, intrauterine device \[IUD\] or surgical sterilization) Note: Females of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator.
- 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 16 units per week for females \[1 unit = 4 cl spirits or equivalent\]).
- Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study(from the screening visit to the end-of study visit).
- Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages during the treatment periods until 24h after study treatment administration.
- Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.
- Administration of another investigational drug within 90 days prior to the first study treatment administration.
- Unsuitable veins for repeated venipuncture or for cannulation.
- Inability to learn the correct inhalation technique (during screening or on a separate visit for training).
- Predictable poor compliance or inability to communicate well with the study centre personnel.
- Inability to participate in all treatment periods.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01181063
Start Date
August 1 2010
End Date
November 1 2010
Last Update
June 10 2011
Active Locations (1)
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1
Phase I Unit, Orion Pharma
Espoo, Finland