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Evaluation of the Pharmacokinetics of Prana P1 Capsules

Healthy Clinical Trial

Official title:
An Open Label ,Phase I, 2-way Crossover Study Evaluating the Pharmacokinetics of Prana P1 THC Activated Capsules

Clinical Trial Summary

This is a single dose clinical trial to assess the Pharmacokinetics of two (2) dosages; 10 mg and 20mg of THC: THCa of Prana P1 bionutrients in healthy volunteers.

Clinical Trial Description

Single oral dose, (10 mg Prana P1 or 20 mg Prana P1) in each period with a washout of 30 days between doses. Patents will be randomly assigned dose for the first round of the study after a thirty-day washout, patient will return to the study site and receive cross over dose.

Metabolites to be Measured:

1. THC

2. 11-OH-THC [primary secondary metabolite of THC, psychoactive]

3. THC-COOH [inactive metabolite]

The following parameters for THC, 11-OH-THC, and THC-COOH will be assessed: AUC0-t, AUC0-inf, Cmax, AUCt/inf, Tmax.

Safety will be monitored and assessed through adverse events reports, 12-lead ECG, vital signs and laboratory parameters. Each participant will undergo a psychometric evaluation using the CHAT assessment tool. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03744091
Study type Interventional
Source The University of The West Indies
Contact
Status Active, not recruiting
Phase Phase 1
Start date July 16, 2018
Completion date August 23, 2019
View Details
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