Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers

Study Overview
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Brief Summary
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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).

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

Conditions
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COPD

Intervention / Treatment
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* Drug: Glycopyrrolate + Formoterol
* Drug: Glycopyrrolate
* Drug: Formoterol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females healthy volunteers aged 18-65 years will be included in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment R2<br> | Drug: Formoterol<br>* formoterol pMDI<br>|
| Active Comparator: Treatment R1<br> | Drug: Glycopyrrolate<br>* glycopyrrolate pMDI<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo pMDI<br>|
| Experimental: Treatment T<br> | Drug: Glycopyrrolate + Formoterol<br>* glycopyrrolate pMDI + formoterol pMDI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: formoterol and glyco AUC0-t | Area under the plasma concentration curve observed from administration up to the last measurable concentration. | from pre-dose to 32 hours after administration | 
| Pharmacokinetics: formoterol and glyco Cmax | Maximum plasma concentration | from pre-dose to 32 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional pharmacokinetic variables | Plasma Glyco AUC0-30min, AUC0-32h, AUC0-inf, tmax and t1/2 - Plasma Formoterol AUC0-30min, AUC0-24h, AUC0-inf, tmax and t1/2. | from pre-dose to 32 hours post dose | 
| Serum potassium | Serum potassium Cmin, tmin and AUC0-24h | From pre-dose to 24 hours after administration | 
| Plasma glucose | Plasma glucose Cmax, tmax and AUC0-24h | from pre-dose to 24 hours after administration | 
| Lung function | FEV1 in order to assess potential occurrence of paradoxical bronchospasm | from pre-dose to 1 hour after administration | 
| Vital signs | heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP). | from pre-dose to 24 hours after administration | 
| ECG | 12-lead ECG parameters: HR, RR, PR, QRS, QT, QTcB, QTcF | from pre-dose to 24 hours after administration |