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Completed

NCT Number: NCT05288075

Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Test Products and Reference Product

This is a formulation feasibility study to to compare relative bioavailability of indacaterol and glycopyrronium after administration of single doses of 3 Easyhaler test products and Ultibro Breezhaler. The study treatments will be administered with concomitant oral charcoal to block absorption via gastrointestinal tract and to assess pulmonary absorption only.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRST Helsinki Oy

Helsinki, Finland

Who can participate

Healthy volunteers accepted: Yes

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

Main Inclusion Criteria:

  • Healthy males and females
  • 18-60 years of age
  • Body mass index 19-30 kg/m2
  • Weight at least 50 kg
  • Written informed consent obtained

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, vital sign or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject
  • Known hypersensitivity to indacaterol or glycopyrronium
  • Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness
  • Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration

Treatment and study plan

Indacaterol/glycopyrronium

Drug

In each period, subjects receive single dose of indacaterol/glycopyrronium consisting of 2 inhaled doses via Easyhaler or 2 capsules inhaled via Ultibro Breezhaler.

In addition to study treatments, activated charcoal will be administered on each study period before and after study drug administration.

Other names: Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A with charcoal, Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B with charcoal, Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C with charcoal, Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule with charcoal

Primary outcomes

  1. Peak indacaterol and glycopyrronium concentration in plasma (Cmax)

    Time frame: between 0-72 hours after dosing

    Pharmacokinetic parameters of indacaterol and glycopyrronium

  2. Area under the concentration-time curve from time zero to 72 hours (AUC72)

    Time frame: between 0-72 hours after dosing

    Pharmacokinetic parameters of indacaterol and glycopyrronium

Secondary outcomes

  1. Time to reach peak indacaterol and glycopyrronium concentration in plasma (tmax)

    Time frame: between 0-72 hours after dosing

    Pharmacokinetic parameters of indacaterol and glycopyrronium

  2. Area under the concentration-time curve from time zero to 30 minutes (AUC30)

    Time frame: between 0-30 minutes after dosing

    Pharmacokinetic parameters of indacaterol and glycopyrronium

Other outcomes

  1. Adverse events

    Time frame: Up to 11 weeks

    Adverse events

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

Pharmacokinetic Formulation Feasibility Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Easyhaler Test Products and Reference Product Ultibro Breezhaler

Acronym: FORELLI

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2022
Registry last updated
Jul 13, 2022

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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