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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 propionate

AUCt 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

Page last updated: August 23, 2015

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