Healthy Volunteers Clinical Trial
Official title:
A Single-Center, Randomized, 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
The primary objective of the study was to evaluate the safety and tolerability of novel oral capsules containing THC and/or CBD, following a single administration to healthy volunteers. The secondary objective of the study was to compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational oral formulations with Sativex® Oromucosal Spray.
Fifteen (15) healthy male volunteers received, following an overnight fasting and a standard
breakfast, a single dose of either one of five administrations: PNL-THC:CBD, P-PNL-THC:CBD,
CBD10 hard capsule, CBD100 hard capsule, Sativex® spray X 4. There was a wash-out period of
no less than 4 days between each dosing.
Subjects underwent screening procedures within 21 days prior to first dosing, to assess their
eligibility to participate in the study. Eligible subjects were admitted to the Clinical
Research Center (CRC) in the evening before each study drug administration and will remained
in-house for 24 hours after dosing. Following an overnight fast of at least 10 hours, the
subjects received a standard meal within 30 minutes prior to dosing. Blood samples for PK
were drawn at the specified time points. The subjects were monitored for safety, and AEs were
recorded throughout the study. An End-of Study (EOS)/Safety Follow-up visit took place on
7-10 days after the last dose of study treatment.
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