NCT05288075

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Indacaterol/glycopyrronium	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.

Timeline

• Start date: 2022-02-28
• Primary completion: 2022-06-27
• Completion: 2022-06-27
• First posted: 2022-03-18
• Last updated: 2022-07-13

Locations

1 site across 1 country: Finland