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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001552-11 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment R2 | Active Comparator |
| |
| Treatment R1 | Active Comparator |
| |
| Placebo | Placebo Comparator |
| |
| Treatment T | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrrolate + Formoterol | Drug | glycopyrrolate pMDI + formoterol pMDI |
| |
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lien Gheyle, MD | Clinical Pharmacology Unit at SGS Life Sciences - Antwerpen (Belgium) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit - SGS Life Science Services | Antwerp | Lange Beeldekensstraat 267 | 2060 | Belgium |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| Glycopyrrolate |
| Drug |
glycopyrrolate pMDI |
|
| Formoterol | Drug | formoterol pMDI |
|
| Placebo | Drug | placebo pMDI |
|
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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |