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

This study has been completed.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A. Identifier:
First received: June 9, 2011
Last updated: April 2, 2012
Last verified: April 2012

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).

Condition Intervention Phase
Drug: Glycopyrrolate + Formoterol
Drug: Glycopyrrolate
Drug: Formoterol
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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.

Resource links provided by NLM:

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Pharmacokinetics: formoterol and glyco AUC0-t [ Time Frame: from pre-dose to 32 hours after administration ] [ Designated as safety issue: No ]
    Area under the plasma concentration curve observed from administration up to the last measurable concentration.

  • Pharmacokinetics: formoterol and glyco Cmax [ Time Frame: from pre-dose to 32 hours after administration ] [ Designated as safety issue: No ]
    Maximum plasma concentration

Secondary Outcome Measures:
  • Additional pharmacokinetic variables [ Time Frame: from pre-dose to 32 hours post dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: From pre-dose to 24 hours after administration ] [ Designated as safety issue: Yes ]
    Serum potassium Cmin, tmin and AUC0-24h

  • Plasma glucose [ Time Frame: from pre-dose to 24 hours after administration ] [ Designated as safety issue: Yes ]
    Plasma glucose Cmax, tmax and AUC0-24h

  • Lung function [ Time Frame: from pre-dose to 1 hour after administration ] [ Designated as safety issue: Yes ]
    FEV1 in order to assess potential occurrence of paradoxical bronchospasm

  • Vital signs [ Time Frame: from pre-dose to 24 hours after administration ] [ Designated as safety issue: Yes ]
    heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP).

  • ECG [ Time Frame: from pre-dose to 24 hours after administration ] [ Designated as safety issue: Yes ]
    12-lead ECG parameters: HR, RR, PR, QRS, QT, QTcB, QTcF

Enrollment: 44
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment R2 Drug: Formoterol
formoterol pMDI
Active Comparator: Treatment R1 Drug: Glycopyrrolate
glycopyrrolate pMDI
Placebo Comparator: Placebo Drug: Placebo
placebo pMDI
Experimental: Treatment T Drug: Glycopyrrolate + Formoterol
glycopyrrolate pMDI + formoterol pMDI


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Males and females healthy volunteers aged 18-65 years will be included in the study.
  Contacts and Locations
Please refer to this study by its identifier: NCT01398111

Clinical Pharmacology Unit - SGS Life Science Services
Antwerpen, Lange Beeldekensstraat 267, Belgium, 2060
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Principal Investigator: Lien Gheyle, MD Clinical Pharmacology Unit at SGS Life Sciences - Antwerpen (Belgium)
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT01398111     History of Changes
Other Study ID Numbers: CCD-1101-PR-0056, 2011-001552-11
Study First Received: June 9, 2011
Last Updated: April 2, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents processed this record on April 17, 2014