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Completed

NCT Number: NCT03238482

Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit, Orion Pharma

Espoo, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Main inclusion Criteria:

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

Main exclusion Criteria:

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
  • Any condition requiring regular concomitant treatment.
  • 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.
  • Known hypersensitivity to the active substance(s) or the lactose.
  • Pregnant or lactating females and females of childbearing potential not using proper contraception.
  • Blood donation or loss of significant amount of blood within 90 days prior to first study treatment administration.
  • Administration of another investigational medicinal product within 90 days prior to first study treatment administration.

Treatment and study plan

salmeterol-fluticasone

Drug

Seretide Diskus 50/250 µg/dose

Primary outcomes

  1. Peak plasma concentration (Cmax) of salmeterol

    Time frame: between 0-34 hours after dosing

    Cmax of salmeterol

  2. Peak plasma concentration (Cmax) of fluticasone propionate

    Time frame: between 0-34 hours after dosing

    Cmax of fluticasone propionate

  3. Area under the plasma concentration versus time curve (AUC) of salmeterol

    Time frame: 0-34 hours after dosing

    AUC from time zero to the last sample with the quantifiable concentration

  4. Area under the plasma concentration versus time curve (AUC) of fluticasone propionate

    Time frame: 0-34 hours after dosing

    AUC from time zero to the last sample with the quantifiable concentration

  5. Truncated area under the plasma concentration versus time curve (AUC) of salmeterol

    Time frame: 0-30 minutes after dosing

    AUC from time zero to 30 min after study treatment administration

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of salmeterol

    Time frame: 0-34 hours after dosing and extrapolation

    AUC from time zero to infinity

  2. Area under the plasma concentration versus time curve (AUC) of fluticasone propionate

    Time frame: 0-34 hours after dosing and extrapolation

    AUC from time zero to infinity

  3. The time to reach the maximum concentration (tmax) of salmeterol

    Time frame: 0-34 hours after dosing

    tmax of salmeterol

  4. The time to reach the maximum concentration (tmax) of fluticasone propionate

    Time frame: 0-34 hours after dosing

    tmax of fluticasone propionate

  5. The terminal elimination half-life (t1/2) of salmeterol

    Time frame: 0-34 hours after dosing

    t1/2 of salmeterol

  6. The terminal elimination half-life (t1/2) of fluticasone propionate

    Time frame: 0-34 hours after dosing

    t1/2 of fluticasone propionate

Other outcomes

  1. Adverse events

    Time frame: through study completion, an average of 6 weeks

    Adverse events

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2017
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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