NCT03744091

Evaluation of the Pharmacokinetics of Prana P1 Capsules

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: The University of The West Indies · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	P1	10 mg or 20 mg of THC:THCa

Timeline

• Start date: 2018-07-16
• Primary completion: 2019-01-23
• Completion: 2019-08-23
• First posted: 2018-11-16
• Last updated: 2019-06-07

Locations

1 site across 1 country: Jamaica