|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 October 2015 |
|
Main ID: |
NCT02162485 |
|
Date of registration:
|
05/06/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus
|
|
Scientific 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 |
|
Date of first enrolment:
|
June 2014 |
|
Target sample size:
|
129 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02162485 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Finland
| | | | | | | |
|
Contacts
|
|
Name:
|
Leena Mattila, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Orion Pharma Clinical Pharmacology Unit, Espoo, Finland |
|
|
Name:
|
Merja Mäkitalo |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Orion Corporation, Orion Pharma |
| |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Asthma
|
|
Intervention(s)
|
|
Drug: Seretide Diskus
|
|
Drug: Salmeterol/fluticasone Easyhaler with charcoal
|
|
Drug: Salmeterol/fluticasone Easyhaler
|
|
Drug: Seretide Diskus with charcoal
|
|
Primary Outcome(s)
|
|
Cmax of plasma salmeterol and fluticasone propionate
[Time Frame: within 34 h]
|
|
AUCt of plasma salmeterol and fluticasone propionate
[Time Frame: 34 h]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|