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NCT Number: NCT01398111

Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers

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).

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit - SGS Life Science Services

Antwerp, Lange Beeldekensstraat 267, 2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Glycopyrrolate + Formoterol

Drug

glycopyrrolate pMDI + formoterol pMDI

Glycopyrrolate

Drug

glycopyrrolate pMDI

Formoterol

Drug

formoterol pMDI

Placebo

Drug

placebo pMDI

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

Open-label, Randomized, Single-dose, Placebo-controlled, 4-way Crossover Study to Investigate the Pharmacokinetic Interaction of Glycopyrrolate and Formoterol in Healthy Subjects.

Acronym: TRIPLE 1

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 20, 2011
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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