Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 318 for:    FLUTICASONE AND SALMETEROL

Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162485
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Brief 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

Condition or disease Intervention/treatment Phase
Asthma Drug: Salmeterol/fluticasone Easyhaler Drug: Salmeterol/fluticasone Easyhaler with charcoal Drug: Seretide Diskus Drug: Seretide Diskus with charcoal Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Salmeterol/fluticasone Easyhaler
Single dose of Salmeterol/fluticasone Easyhaler
Drug: Salmeterol/fluticasone Easyhaler
Experimental: Salmeterol/fluticasone Easyhaler with charcoal
Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration (Carbomix granules)
Drug: Salmeterol/fluticasone Easyhaler with charcoal
Active Comparator: Seretide Diskus
Single dose of Seretide Diskus
Drug: Seretide Diskus
Active Comparator: Seretide Diskus with charcoal
Single dose of Seretide Diskus with concomitant charcoal administration (Carbomix granules)
Drug: Seretide Diskus with charcoal



Primary Outcome Measures :
  1. Cmax of plasma salmeterol and fluticasone propionate [ Time Frame: within 34 h ]
  2. AUCt of plasma salmeterol and fluticasone propionate [ Time Frame: 34 h ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162485


Locations
Layout table for location information
Finland
Orion Pharma Pharmacology Unit
Espoo, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Layout table for investigator information
Study Director: Merja Mäkitalo Orion Corporation, Orion Pharma
Principal Investigator: Leena Mattila, MD, PhD Orion Pharma Clinical Pharmacology Unit, Espoo, Finland

Layout table for additonal information
Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT02162485     History of Changes
Other Study ID Numbers: 3106009
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Charcoal
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics
Antidotes
Protective Agents