Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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 inhaled dosage forms is not generally known.

The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH product variants under development and compare pulmonary deposition (administration with charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.

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

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.