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Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler

NCT04856098 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-09-28

No results posted yet for this study

Summary

The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Indacaterol maleate and glycopyrronium bromide

Batch A Ultibro Breezhaler 85/43 μg 2 capsules

DRUG

Indacaterol maleate and glycopyrronium bromide

Batch A Ultibro Breezhaler 85/43 μg 1 capsule

DRUG

Indacaterol maleate and glycopyrronium bromide

Batch B Ultibro Breezhaler 85/43 μg 2 capsules

DRUG

Ultibro Breezhaler with oral charcoal

Activated charcoal suspension, granules 50 g / bottle

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Orion Corporation 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
2021-05-07
Primary Completion
2021-09-21
Completion
2021-09-21

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 NCT04856098 on ClinicalTrials.gov