Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers

COPD Clinical Trial

— TRIPLE 1  

Official title:

Open-label, Randomized, Single-dose, Placebo-controlled, 4-way Crossover Study to Investigate the Pharmacokinetic Interaction of Glycopyrrolate and Formoterol in Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398111
• Other study ID #: CCD-1101-PR-0056
• Secondary ID: 2011-001552-11
• Status: Completed
• Phase: Phase 1
• Start date: May 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and females healthy volunteers aged 18-65 years will be included in the study.

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• Glycopyrrolate + Formoterol
glycopyrrolate pMDI + formoterol pMDI
• Glycopyrrolate
glycopyrrolate pMDI
• Formoterol
formoterol pMDI
• Placebo
placebo pMDI

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit - SGS Life Science Services	Antwerpen	Lange Beeldekensstraat 267

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: formoterol and glyco AUC0-t	Area under the plasma concentration curve observed from administration up to the last measurable concentration.	from pre-dose to 32 hours after administration
Primary	Pharmacokinetics: formoterol and glyco Cmax	Maximum plasma concentration	from pre-dose to 32 hours after administration
Secondary	Additional pharmacokinetic variables	Plasma Glyco AUC0-30min, AUC0-32h, AUC0-inf, tmax and t1/2 - Plasma Formoterol AUC0-30min, AUC0-24h, AUC0-inf, tmax and t1/2.	from pre-dose to 32 hours post dose
Secondary	Serum potassium	Serum potassium Cmin, tmin and AUC0-24h	From pre-dose to 24 hours after administration
Secondary	Plasma glucose	Plasma glucose Cmax, tmax and AUC0-24h	from pre-dose to 24 hours after administration
Secondary	Lung function	FEV1 in order to assess potential occurrence of paradoxical bronchospasm	from pre-dose to 1 hour after administration
Secondary	Vital signs	heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP).	from pre-dose to 24 hours after administration
Secondary	ECG	12-lead ECG parameters: HR, RR, PR, QRS, QT, QTcB, QTcF	from pre-dose to 24 hours after administration

External Links

•   CSR Synopsis available in the Chiesi Clinical Study Register