Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus
Information source: Orion Corporation, Orion Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Salmeterol/fluticasone Easyhaler (Drug); Salmeterol/fluticasone Easyhaler with charcoal (Drug); Seretide Diskus (Drug); Seretide Diskus with charcoal (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Orion Corporation, Orion Pharma Official(s) and/or principal investigator(s): Merja Mäkitalo, Study Director, Affiliation: Orion Corporation, Orion Pharma Leena Mattila, MD, PhD, Principal Investigator, Affiliation: Orion Pharma Clinical Pharmacology Unit, Espoo, Finland
Overall contact: Minna Nissilä, MSc, Phone: +358 10 4261, Email: minna.nissila@orionharma.com
Summary
The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler
with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream
Clinical Details
Official title: Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus 50/500 µG/Inhalation; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cmax of plasma salmeterol and fluticasone propionateAUCt of plasma salmeterol and fluticasone propionate
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Written informed consent obtained
- Good general health ascertained by detailed medical history, and laboratory and
physical examinations
Exclusion Criteria:
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological,
GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the
previous 2 years
- 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
- Known hypersensitivity to the active substance(s) or the excipient (lactose, which
contains small amounts of milk protein) of the drug
- Pregnant or lactating females
Locations and Contacts
Minna Nissilä, MSc, Phone: +358 10 4261, Email: minna.nissila@orionharma.com
Orion Pharma Pharmacology Unit, Espoo, Finland; Recruiting Minna Nissilä, Phone: +358 10 4261, Email: minna.nissila@orionpharma.com Leena Mattila, MD, PhD, Principal Investigator
Additional Information
Starting date: June 2014
Last updated: June 12, 2014
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