Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)

Asthma Clinical Trial

Official title:

Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler 50/250 µg/Dose Products and Seretide Diskus 50/250 µg/Dose in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238482
• Other study ID #: 3106012
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2017
• Last updated: April 5, 2018
• Start date: August 16, 2017
• Est. completion date: December 19, 2017

Study information

• Verified date: April 2018
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 19, 2017
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• salmeterol-fluticasone
Seretide Diskus 50/250 µg/dose
• salmeterol-fluticasone
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E
• salmeterol-fluticasone
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F
• salmeterol-fluticasone
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G

Locations

Country	Name	City	State
Finland	Clinical Pharmacology Unit, Orion Pharma	Espoo

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse events	through study completion, an average of 6 weeks
Primary	Peak plasma concentration (Cmax) of salmeterol	Cmax of salmeterol	between 0-34 hours after dosing
Primary	Peak plasma concentration (Cmax) of fluticasone propionate	Cmax of fluticasone propionate	between 0-34 hours after dosing
Primary	Area under the plasma concentration versus time curve (AUC) of salmeterol	AUC from time zero to the last sample with the quantifiable concentration	0-34 hours after dosing
Primary	Area under the plasma concentration versus time curve (AUC) of fluticasone propionate	AUC from time zero to the last sample with the quantifiable concentration	0-34 hours after dosing
Primary	Truncated area under the plasma concentration versus time curve (AUC) of salmeterol	AUC from time zero to 30 min after study treatment administration	0-30 minutes after dosing
Secondary	Area under the plasma concentration versus time curve (AUC) of salmeterol	AUC from time zero to infinity	0-34 hours after dosing and extrapolation
Secondary	Area under the plasma concentration versus time curve (AUC) of fluticasone propionate	AUC from time zero to infinity	0-34 hours after dosing and extrapolation
Secondary	The time to reach the maximum concentration (tmax) of salmeterol	tmax of salmeterol	0-34 hours after dosing
Secondary	The time to reach the maximum concentration (tmax) of fluticasone propionate	tmax of fluticasone propionate	0-34 hours after dosing
Secondary	The terminal elimination half-life (t1/2) of salmeterol	t1/2 of salmeterol	0-34 hours after dosing
Secondary	The terminal elimination half-life (t1/2) of fluticasone propionate	t1/2 of fluticasone propionate	0-34 hours after dosing