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

NCT05288075 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-07-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Orion Corporation Clinical Study Director · Orion Corporation, Orion Pharma

  • Clinical Study Director · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05288075 on ClinicalTrials.gov