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5-Way Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of New Oral Cannabinoid Formulations Administered as Single Doses, With Buccal Sativex®, in Healthy Volunteers

2017-06-29 05:53:21 | BioPortfolio

Summary

Fifteen (15) healthy male volunteers will receive, following an overnight fasting and a standard breakfast, a single dose of either one of five different administrations.Subjects will undergo screening procedures within 21 days prior to first dosing. Eligible subjects will be admitted to the Clinical Research Center (CRC) in the evening before each study drug administration and will remain in-house for 24 hours after dosing. Following an overnight fast of at least 10 hours, the subjects will receive a standard meal within 30 minutes prior to dosing. Blood samples for PK will be drawn at specified time points. An End-of Study (EOS)/Safety Follow-up visit will take place on 7-10 days after the last dose of study treatment.

Description

Fifteen (15) healthy male volunteers will receive, following an overnight fasting and a standard breakfast, a single dose of either one of five administrations: 3 soft capsules of PNL-THC:CBD, 2 soft capsules of P-PNL-THC:CBD, 1 hard capsule of CBD10, hard capsule of CBD100, Sativex® spray X 4 actuations. There will be a wash-out period of no less than 4 days between each dosing.

Subjects will undergo screening procedures within 21 days prior to first dosing, to assess their eligibility to participate in the study. Eligible subjects will be admitted to the Clinical Research Center (CRC) in the evening before each study drug administration and will remain in-house for 24 hours after dosing. Following an overnight fast of at least 10 hours, the subjects will receive a standard meal within 30 minutes prior to dosing. Blood samples for PK will be drawn at the specified time points. The subjects will be monitored for safety, and AEs will be recorded throughout the study. An End-of Study (EOS)/Safety Follow-up visit will take place on 7-10 days after the last dose of study treatment.

Study Design

Conditions

Healthy Volunteers

Intervention

PNL-THC:CBD, Sativex, CBD

Location

Clinical Research Center (CRC)- Souraskey Medical center
Tel Aviv
Israel

Status

Completed

Source

PhytoTech Therapeutics, Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-06-29T05:53:21-0400

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