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The purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled Glyco pMDI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glyco pMDI | Experimental | Glyco pMDI 100 µg |
|
| Glyco pMDI Charcoal | Experimental | Glyco pMDI 100 µg + charcoal block |
|
| Glyco IV injection | Active Comparator | Glyco solution for injection 100 µg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrrolate | Drug | Single administration of Glyco pMDI 100 µg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and urine pharmacokinetics of glycopyrrolate | over 24 h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function parameters | over 24 h post dose | |
| Cardiovascular parameters | over 24 h post dose | |
| Clinical chemistry and haematology, urinalysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dave Singh, MD | Medicines Evaluation Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicines Evaluation Unit | Manchester | M23 9QZ | United Kingdom |
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| Glycopyrrolate | Drug | Single administration of Glyco pMDI 100 µg after charcoal ingestion |
|
|
| Glycopyrrolate | Drug | Single intravenous injection of glycopyrrolate 100 µg |
|
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| over 24 h post dose |
| Adverse Events | during the whole study period |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |