Who is sponsoring NCT01893424?

NCT01893424 is sponsored by Hadassah Medical Organization.

What drugs are being tested in NCT01893424?

Interventions: Sativex buccal spray, CBD-THC-Piperine-PNL capsule.

What is the status of NCT01893424?

NCT01893424 is currently COMPLETED.

Last reviewed 2016-03-23 · How we verify

Bioequivalence Assessment of Oral Administration Vs. Oral Spray of a Cannabinoid Combination (Δ9 -Tetrahydrocannabinol (THC) and Cannabidiol (CBD) In 1:1 Ratio)

NCT01893424 Phase 1 COMPLETED

This project is intended to evaluate self-emulsifying drug delivery system termed Piperine-Pro-Nano-Lipospheres (P-PNL) for enhancing the oral bioavailability of tetrahydrocannabinol (THC) and cannabidiol (CBD).The oral bioavailability of these cannabinoids is hampered by extensive first pass metabolism, resulting in relative bioavailability of 6%. The main goal of this study is to evaluate the bioequivalence of THC-CBD P-PNL product for oral administration to Sativex® buccal spray, as measured by AUC 0-24h, Tmax and Cmax.

Details

Lead sponsor	Hadassah Medical Organization
Phase	Phase 1
Status	COMPLETED
Enrolment	12
Start date	2013-08
Completion	2015-01

Conditions

Pain

Interventions

Sativex buccal spray
CBD-THC-Piperine-PNL capsule

Primary outcomes

Pharmacokinetic parameters of THC and CBD — 1 year

Countries

Israel