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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Indacaterol/glycopyrronium

• Registration Number: NCT05288075
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-07
• Study Start: 2022-02-28
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-18
• Primary Completion: 2022-06-27
• Study Completion: 2022-06-27
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Healthy males and females
2. 18-60 years of age
3. Body mass index 19-30 kg/m2
4. Weight at least 50 kg
5. Written informed consent obtained

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, 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
4. Known hypersensitivity to indacaterol or glycopyrronium
5. Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness
6. Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A	Indacaterol/glycopyrronium	Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant A in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses).
Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B	Indacaterol/glycopyrronium	Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant B in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses).
Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule	Indacaterol/glycopyrronium	Each subject will receive 2 capsules of Ultibro® Breezhaler® (=Indacaterol/glycopyrronium) as a single dose in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses).
Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C	Indacaterol/glycopyrronium	Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant C in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses).

Primary Outcome Measures

Name	Time	Method
Peak indacaterol and glycopyrronium concentration in plasma (Cmax)	between 0-72 hours after dosing	Pharmacokinetic parameters of indacaterol and glycopyrronium
Area under the concentration-time curve from time zero to 72 hours (AUC72)	between 0-72 hours after dosing	Pharmacokinetic parameters of indacaterol and glycopyrronium

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve from time zero to 30 minutes (AUC30)	between 0-30 minutes after dosing	Pharmacokinetic parameters of indacaterol and glycopyrronium
Time to reach peak indacaterol and glycopyrronium concentration in plasma (tmax)	between 0-72 hours after dosing	Pharmacokinetic parameters of indacaterol and glycopyrronium

Trial Locations

Locations (1)

CRST Helsinki Oy; 🇫🇮 Helsinki, Finland