Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers (TRIPLE 1)

Chiesi

Status and phase: Completed; Phase 1

Conditions: COPD

Treatments: Drug: Glycopyrrolate + Formoterol; Drug: Placebo; Drug: Formoterol; Drug: Glycopyrrolate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01398111

CCD-1101-PR-0056

2011-001552-11 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 4 patient groups, including a placebo group

Treatment R2

Active Comparator group

Treatment:

Drug: Formoterol

Treatment R1

Active Comparator group

Treatment:

Drug: Glycopyrrolate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Treatment T

Experimental group

Treatment:

Drug: Glycopyrrolate + Formoterol