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| Name | Class |
|---|---|
| Algorithme Pharma Inc | INDUSTRY |
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The primary objective of this study was to evaluate the pharmacokinetics (PK) of THC, 11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization.
The secondary objective of this study was to determine the safety and tolerability of THC and CBD after a single inhaled dose of PPP001 administered by vaporization in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inhaled THC/CBD (PPP001) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPP001 | Drug | inhalation (vape) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events [Safety and Tolerability] | To evaluate treatment-related adverse events of PPP001 | over 5 days |
| Biochemistry test results [Safety and Tolerability] | Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase | over 5 days |
| Temperature [Safety and Tolerability] | Oral temperature in Celsius | over 5 days |
| Pulse rate [Safety and Tolerability] | Pulse rate (in beats per minute) | over 5 days |
| Blood pressure [Safety and Tolerability] | Blood pressure (systolic/diastolic blood pressure in mm Hg) | over 5 days |
| Clinically significant ECG abnormalities [Safety and Tolerability] | Number of subjects with clinically significant ECG abnormalities (measured with a 12-lead ECG) | over 5 days |
| Plasma concentrations of delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics) | over 5 days | |
| Plasma concentrations of 11-OH-delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics) | over 5 days |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alta sciences | Montreal | Quebec | Canada |
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| Plasma concentrations of cannabidiol produced by PPP001 were determined. (pharmacokinetics) | over 5 days |