Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers (REFLI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01668121
First received: August 15, 2012
Last updated: November 22, 2012
Last verified: August 2012
  Purpose

The primary objective of this study is to evaluate the acceptance range with which two Symbicort Turbohaler batches could be declared bioequivalent in a bioequivalence setting. The secondary objective is to compare pharmacokinetic parameters of the reference product batches and Budesonide/formoterol Easyhaler.


Condition Intervention Phase
Asthma
Drug: Symbicort Turbohaler
Drug: Budesonide/formoterol Easyhaler
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Two Batches of Symbicort Turbuhaler and Budesonide/Formoterol Easyhaler: Randomised, Double-blind, Double-dummy, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Pharmacokinetic parameter Cmax of plasma Budesonide concentration [ Time Frame: within 12 h ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter AUCt of plasma Budesonide concentration [ Time Frame: within 12 h ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter Cmax of plasma Formoterol concentration [ Time Frame: within 24 h ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter AUCt of plasma Formoterol concentration [ Time Frame: within 24 h ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Symbicort Turbohaler
Symbicort Turbohaler
Drug: Symbicort Turbohaler Drug: Budesonide/formoterol Easyhaler
Active Comparator: Budesonide/formoterol Easyhaler
Budesonide/formoterol Easyhaler
Drug: Symbicort Turbohaler Drug: Budesonide/formoterol Easyhaler

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Written informed consent (IC) obtained.
  2. Males and females, 18-55 (inclusive) years of age.
  3. Normal weight defined as body mass index (BMI) > 19 and < 30 kg/m2 (BMI= weight/height2).
  4. Weight at least 50 kg.
  5. Forced expiratory volume in one second (FEV1) at least 80% of the predicted value measured at the screening.
  6. Good general health ascertained by detailed medical history, and laboratory and physical examinations.

Exclusion Criteria:

  1. Vulnerable subjects (i.e. persons under any administrative or legal supervision).
  2. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease within previous 2 years; or evidence of active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
  3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain are allowed.
  4. Intake of any medication that could affect the outcome of the study. As an exception, contraceptives and hormone replacement therapy are allowed. The use of medicines which are strong CYP3A4 inducers or inhibitors are restricted for at least 2 weeks prior to the first study treatment administration and during the study.
  5. 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. More specifically, supine HR < 45 or > 100 bpm after 10-min rest or supine systolic BP >140 or < 90 or diastolic BP > 90 or < 60 mmHg after a 10-minute rest, or a QTc-Bazett (QTcB interval) > 450 msec at screening evaluation.
  6. Known hypersensitivity to the active substances or the excipient (lactose, which contains small amounts of milk protein) of the drug.
  7. History of vasovagal collapses.
  8. History of anaphylactic/anaphylactoid reactions.
  9. History of seizures including febrile seizures.
  10. Pregnant or lactating females.
  11. Females of childbearing potential if they are not using proper contraception (mechanical and/or hormonal contraception, intrauterine device [IUD] or surgical sterilization). Double method of contraception is needed when using oral or mechanical contraception: e.g. condom in conjunct with oral contraception and spermicidal product with mechanical contraception (please see section 5.7 for details).
  12. Recent or current (suspected) drug abuse or positive result in the drugs abuse test.
  13. 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]).
  14. 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).
  15. 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 24 h after study treatment administration.
  16. Blood donation or loss of significant amount of blood within 30 days prior to the first study treatment administration.
  17. Administration of another investigational drug within 30 days prior to the first study treatment administration.
  18. Unsuitable veins for repeated venepuncture or for cannulation.
  19. Inability to learn the correct inhalation technique.
  20. Predictable poor compliance or inability to communicate well with the study centre personnel.
  21. Inability to participate in all treatment periods.
  22. The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
  23. Positive result in HIV, hepatitis B or C tests.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668121

Locations
Germany
PAREXEL International GmbH
Berlin, Germany
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Rainard Fuhr, MD Parexel International GmbH
Study Director: Merja Mäkitalo Orion Corporation, Orion Pharma
  More Information

No publications provided

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01668121     History of Changes
Other Study ID Numbers: 3103012
Study First Received: August 15, 2012
Last Updated: November 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014