Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler (FINDA)

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Ultibro Breezhaler with oral charcoal; Drug: Indacaterol maleate and glycopyrronium bromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04856098

3131001

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main 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

Main 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 5 patient groups

Part 1 Ultibro Breezhaler 2 capsules, Batch A

Experimental group

Treatment:

Drug: Indacaterol maleate and glycopyrronium bromide

Drug: Indacaterol maleate and glycopyrronium bromide

Drug: Indacaterol maleate and glycopyrronium bromide

Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A

Experimental group

Treatment:

Drug: Indacaterol maleate and glycopyrronium bromide

Drug: Indacaterol maleate and glycopyrronium bromide

Drug: Indacaterol maleate and glycopyrronium bromide

Drug: Ultibro Breezhaler with oral charcoal

Part 1 Ultibro Breezhaler 1 capsule, Batch A

Experimental group

Treatment:

Drug: Indacaterol maleate and glycopyrronium bromide

Drug: Indacaterol maleate and glycopyrronium bromide

Drug: Indacaterol maleate and glycopyrronium bromide

Part 2 Ultibro Breezhaler 2 capsules, Batch A

Experimental group

Treatment:

Drug: Indacaterol maleate and glycopyrronium bromide

Drug: Indacaterol maleate and glycopyrronium bromide

Drug: Indacaterol maleate and glycopyrronium bromide

Part 2 Ultibro Breezhaler 2 capsules, Batch B

Experimental group

Treatment:

Drug: Indacaterol maleate and glycopyrronium bromide

Drug: Indacaterol maleate and glycopyrronium bromide

Drug: Indacaterol maleate and glycopyrronium bromide