Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-07

Study Completion Date

2021-09-21

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study is a 2-part crossover study where the study subjects participate either in part 1 (18 subjects) or in part 2 (16 subjects). The parts can run in sequence or in parallel. The study subjects in part 1 receive single doses of Ultibro Breezhaler on 3 periods and the study subjects in part 2 receive single doses of Ultibro Breezhaler on 2 periods.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1 Ultibro Breezhaler 2 capsules, Batch A

Group Type EXPERIMENTAL

Indacaterol maleate and glycopyrronium bromide

Intervention Type DRUG

Batch A Ultibro Breezhaler 85/43 μg 2 capsules

Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A

Group Type EXPERIMENTAL

Indacaterol maleate and glycopyrronium bromide

Intervention Type DRUG

Batch A Ultibro Breezhaler 85/43 μg 2 capsules

Ultibro Breezhaler with oral charcoal

Intervention Type DRUG

Activated charcoal suspension, granules 50 g / bottle

Part 1 Ultibro Breezhaler 1 capsule, Batch A

Group Type EXPERIMENTAL

Indacaterol maleate and glycopyrronium bromide

Intervention Type DRUG

Batch A Ultibro Breezhaler 85/43 μg 1 capsule

Part 2 Ultibro Breezhaler 2 capsules, Batch A

Group Type EXPERIMENTAL

Indacaterol maleate and glycopyrronium bromide

Intervention Type DRUG

Batch A Ultibro Breezhaler 85/43 μg 2 capsules

Part 2 Ultibro Breezhaler 2 capsules, Batch B

Group Type EXPERIMENTAL

Indacaterol maleate and glycopyrronium bromide

Intervention Type DRUG

Batch B Ultibro Breezhaler 85/43 μg 2 capsules

Interventions

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Indacaterol maleate and glycopyrronium bromide

Batch A Ultibro Breezhaler 85/43 μg 2 capsules

Intervention Type DRUG

Indacaterol maleate and glycopyrronium bromide

Batch A Ultibro Breezhaler 85/43 μg 1 capsule

Intervention Type DRUG

Indacaterol maleate and glycopyrronium bromide

Batch B Ultibro Breezhaler 85/43 μg 2 capsules

Intervention Type DRUG

Ultibro Breezhaler with oral charcoal

Activated charcoal suspension, granules 50 g / bottle

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes