Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers

Phase 1

Completed

• Conditions: COPD
• Interventions: Drug: Placebo; Drug: Glycopyrrolate + Formoterol; Drug: Formoterol; Drug: Glycopyrrolate

• Registration Number: NCT01398111
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Treatment T	Glycopyrrolate + Formoterol	-
Treatment R2	Formoterol	-
Treatment R1	Glycopyrrolate	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: formoterol and glyco AUC0-t	from pre-dose to 32 hours after administration	Area under the plasma concentration curve observed from administration up to the last measurable concentration.
Pharmacokinetics: formoterol and glyco Cmax	from pre-dose to 32 hours after administration	Maximum plasma concentration

Secondary Outcome Measures

Name	Time	Method
Lung function	from pre-dose to 1 hour after administration	FEV1 in order to assess potential occurrence of paradoxical bronchospasm
Vital signs	from pre-dose to 24 hours after administration	heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP).
ECG	from pre-dose to 24 hours after administration	12-lead ECG parameters: HR, RR, PR, QRS, QT, QTcB, QTcF
Additional pharmacokinetic variables	from pre-dose to 32 hours post dose	Plasma Glyco AUC0-30min, AUC0-32h, AUC0-inf, tmax and t1/2 - Plasma Formoterol AUC0-30min, AUC0-24h, AUC0-inf, tmax and t1/2.
Serum potassium	From pre-dose to 24 hours after administration	Serum potassium Cmin, tmin and AUC0-24h
Plasma glucose	from pre-dose to 24 hours after administration	Plasma glucose Cmax, tmax and AUC0-24h

Trial Locations

Locations (1)

Clinical Pharmacology Unit - SGS Life Science Services; 🇧🇪 Antwerpen, Lange Beeldekensstraat 267, Belgium