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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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents processed this record on October 21, 2016