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

Healthy Volunteers Clinical Trial

— FORELLI  

Official title:

Pharmacokinetic Formulation Feasibility Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Easyhaler Test Products and Reference Product Ultibro Breezhaler

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05288075
• Other study ID #: 3131002
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2022
• Est. completion date: June 27, 2022

Study information

• Verified date: July 2022
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 27, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
Finland	CRST Helsinki Oy	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse events	Up to 11 weeks
Primary	Peak indacaterol and glycopyrronium concentration in plasma (Cmax)	Pharmacokinetic parameters of indacaterol and glycopyrronium	between 0-72 hours after dosing
Primary	Area under the concentration-time curve from time zero to 72 hours (AUC72)	Pharmacokinetic parameters of indacaterol and glycopyrronium	between 0-72 hours after dosing
Secondary	Time to reach peak indacaterol and glycopyrronium concentration in plasma (tmax)	Pharmacokinetic parameters of indacaterol and glycopyrronium	between 0-72 hours after dosing
Secondary	Area under the concentration-time curve from time zero to 30 minutes (AUC30)	Pharmacokinetic parameters of indacaterol and glycopyrronium	between 0-30 minutes after dosing