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Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler 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: Seretide Diskus and charcoal (Drug); Seretide Diskus (Drug); SF Easyhaler and charcoal (Drug); SF Easyhaler (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Orion Corporation, Orion Pharma

Official(s) and/or principal investigator(s):
Leena Mattila, MD, PhD, Principal Investigator, Affiliation: Orion Corporation, Orion Pharma
Maria Sokka, Study Director, Affiliation: IRW Consulting

Summary

The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.

Clinical Details

Official title: Bioequivalence Study Comparing Two Salmeterol/Fluticasone Propionate Dry Powder Inhalers, SF Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary outcome:

Pharmacokinetic parameter Cmax of plasma salmeterol concentration

Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration

Pharmacokinetic parameter AUCt of plasma salmeterol concentration

Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy males and females aged 18-60 years

- Normal weight, at least 50 kg

Exclusion Criteria:

- Evidence of clinically significant cardiovascular, renal, hepatic, haematological,

GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.

- Any clinically significant abnormal laboratory value or physical finding that may

interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.

- Any condition requiring regular concomitant treatment (including vitamins and herbal

products) or likely to need any concomitant treatment during the study.

- Known hypersensitivity to the active substance(s) or the excipient of the drug.

- Pregnant or lactating females.

Locations and Contacts

Orion Pharma Clinical Pharmacology Unit, Espoo, Finland
Additional Information

Starting date: January 2013
Last updated: January 2, 2014

Page last updated: August 23, 2015

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