Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler

• Status: Completed
• Trial end date: 2021-09-21
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Bromides; Charcoal; Glycopyrrolate; Maleic acid

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