Clinical trial NCT03238482: Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)
Official title: Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler 50/250 µg/Dose Products and Seretide Diskus 50/250 µg/Dose in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2017-08-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare absorption of salmeterol and fluticasone from Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide Diskus


Eligibility criteria: Main inclusion Criteria:

1. Written informed consent (IC) obtained.
2. Males and females, 18-60 (inclusive) years of age.
3. Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI = weight/height2).
4. Weight at least 50 kg.

Main exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
2. Any condition requiring regular concomitant treatment.
3. Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
4. Known hypersensitivity to the active substance(s) or the lactose.
5. Pregnant or lactating females and females of childbearing potential not using proper contraception.
6. Blood donation or loss of significant amount of blood within 90 days prior to first study treatment administration.
7. Administration of another investigational medicinal product within 90 days prior to first study treatment administration.

Primary outcomes:
measure: Peak plasma concentration (Cmax) of salmeterol
timeFrame: between 0-34 hours after dosing
measure: Peak plasma concentration (Cmax) of fluticasone propionate
timeFrame: between 0-34 hours after dosing
measure: Area under the plasma concentration versus time curve (AUC) of salmeterol
timeFrame: 0-34 hours after dosing
measure: Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
timeFrame: 0-34 hours after dosing
measure: Truncated area under the plasma concentration versus time curve (AUC) of salmeterol
timeFrame: 0-30 minutes after dosing
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of salmeterol
timeFrame: 0-34 hours after dosing and extrapolation
measure: Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
timeFrame: 0-34 hours after dosing and extrapolation
measure: The time to reach the maximum concentration (tmax) of salmeterol
timeFrame: 0-34 hours after dosing
measure: The time to reach the maximum concentration (tmax) of fluticasone propionate
timeFrame: 0-34 hours after dosing
measure: The terminal elimination half-life (t1/2) of salmeterol
timeFrame: 0-34 hours after dosing
measure: The terminal elimination half-life (t1/2) of fluticasone propionate
timeFrame: 0-34 hours after dosing
Other outcomes:
measure: Adverse events
timeFrame: through study completion, an average of 6 weeks
Locations:
city: Espoo
country: Finland
facility: Clinical Pharmacology Unit, Orion Pharma
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Ulla Sairanen
role: STUDY_DIRECTOR
References: