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Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01398111
Acronym
TRIPLE 1
Enrollment
44
Registered
2011-07-20
Start date
2011-05-31
Completion date
2011-08-31
Last updated
2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

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).

Interventions

DRUGGlycopyrrolate + Formoterol

glycopyrrolate pMDI + formoterol pMDI

DRUGGlycopyrrolate

glycopyrrolate pMDI

DRUGFormoterol

formoterol pMDI

DRUGPlacebo

placebo pMDI

Sponsors

Chiesi Farmaceutici S.p.A.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Pharmacokinetics: formoterol and glyco AUC0-tfrom pre-dose to 32 hours after administrationArea under the plasma concentration curve observed from administration up to the last measurable concentration.
Pharmacokinetics: formoterol and glyco Cmaxfrom pre-dose to 32 hours after administrationMaximum plasma concentration

Secondary

MeasureTime frameDescription
Plasma glucosefrom pre-dose to 24 hours after administrationPlasma glucose Cmax, tmax and AUC0-24h
Lung functionfrom pre-dose to 1 hour after administrationFEV1 in order to assess potential occurrence of paradoxical bronchospasm
Additional pharmacokinetic variablesfrom pre-dose to 32 hours post dosePlasma Glyco AUC0-30min, AUC0-32h, AUC0-inf, tmax and t1/2 - Plasma Formoterol AUC0-30min, AUC0-24h, AUC0-inf, tmax and t1/2.
ECGfrom pre-dose to 24 hours after administration12-lead ECG parameters: HR, RR, PR, QRS, QT, QTcB, QTcF
Vital signsfrom pre-dose to 24 hours after administrationheart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP).
Serum potassiumFrom pre-dose to 24 hours after administrationSerum potassium Cmin, tmin and AUC0-24h

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026