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

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ClinicalTrials.gov Identifier: NCT01398111
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : April 3, 2012
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
COPD Drug: Glycopyrrolate + Formoterol Drug: Glycopyrrolate Drug: Formoterol Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : May 2011
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics: formoterol and glyco AUC0-t [ Time Frame: from pre-dose to 32 hours after administration ]
    Area under the plasma concentration curve observed from administration up to the last measurable concentration.

  2. Pharmacokinetics: formoterol and glyco Cmax [ Time Frame: from pre-dose to 32 hours after administration ]
    Maximum plasma concentration

Secondary Outcome Measures :
  1. Additional pharmacokinetic variables [ Time Frame: 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.

  2. Serum potassium [ Time Frame: From pre-dose to 24 hours after administration ]
    Serum potassium Cmin, tmin and AUC0-24h

  3. Plasma glucose [ Time Frame: from pre-dose to 24 hours after administration ]
    Plasma glucose Cmax, tmax and AUC0-24h

  4. Lung function [ Time Frame: from pre-dose to 1 hour after administration ]
    FEV1 in order to assess potential occurrence of paradoxical bronchospasm

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

  6. ECG [ Time Frame: from pre-dose to 24 hours after administration ]
    12-lead ECG parameters: HR, RR, PR, QRS, QT, QTcB, QTcF

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
ClinicalTrials.gov Identifier: NCT01398111     History of Changes
Other Study ID Numbers: CCD-1101-PR-0056
2011-001552-11 ( EudraCT Number )
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: April 2012

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