Safety & Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

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.

NCT number	NCT04461756
Study type	Interventional
Source	Tetra Bio-Pharma
Contact
Status	Completed
Phase	Phase 1
Start date	November 1, 2018
Completion date	November 24, 2018

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Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

Clinical Trial Summary

Clinical Trial Description

Study Design

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