Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2017-12-19

Brief Summary

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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

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Seretide Diskus

salmeterol-fluticasone 2 inhalations as a single dose

Group Type ACTIVE_COMPARATOR

salmeterol-fluticasone

Intervention Type DRUG

Seretide Diskus 50/250 µg/dose

Salmeterol/fluticasone Easyhaler, E

salmeterol-fluticasone 2 inhalations as a single dose

Group Type EXPERIMENTAL

salmeterol-fluticasone

Intervention Type DRUG

Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E

Salmeterol/fluticasone Easyhaler, F

salmeterol-fluticasone 2 inhalations as a single dose

Group Type EXPERIMENTAL

salmeterol-fluticasone

Intervention Type DRUG

Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F

Salmeterol/fluticasone Easyhaler, G

salmeterol-fluticasone 2 inhalations as a single dose

Group Type EXPERIMENTAL

salmeterol-fluticasone

Intervention Type DRUG

Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G

Interventions

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salmeterol-fluticasone

Seretide Diskus 50/250 µg/dose

Intervention Type DRUG

salmeterol-fluticasone

Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E

Intervention Type DRUG

salmeterol-fluticasone

Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F

Intervention Type DRUG

salmeterol-fluticasone

Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes