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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01398111
First received: June 9, 2011
Last updated: April 2, 2012
Last verified: April 2012
History of Changes
  Purpose

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
COPD
 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:

U.S. FDA Resources

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01398111

Locations
Belgium
Clinical Pharmacology Unit - SGS Life Science Services
Antwerpen, Lange Beeldekensstraat 267, Belgium, 2060
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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.
ClinicalTrials.gov 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:
Glycopyrrolate
Formoterol
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

ClinicalTrials.gov processed this record on May 21, 2013