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drugset / Trial / NCT05288075

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

NCT05288075 ↗

Phase 1 Completed 24 enrolled Orion Corporation, Orion Pharma
RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2022-02-28
Primary completion
2022-06-27
Completion
2022-06-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycopyrronium Unknown 86 ug Inhaled
Subject Indacaterol Other / unclassified 170 ug Inhaled

Indications

No indication recorded.