NCT01893424

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Aug 2013

Typical duration for phase_1 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

June 16, 2013

Last Update Submit

March 23, 2016

Conditions

Pain

Keywords

Biological AvailabilityPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters of THC and CBD

    1 year

Secondary Outcomes (1)

  • exposure to the metabolites of the study drugs

    1 year

Study Arms (2)

Sativex buccal spray

ACTIVE COMPARATOR

volunteers will receive a single dose of 8 actuations of Sativex® which will be administrated within 1-2 min by the study physician. The dose of THC and CBD to be administered is the following: THC 21.6 mg and CBD 20 mg. Sativex® actuations will be directed sublingually and at the buccal mucosa.

Drug: Sativex buccal spray

CBD-THC-Piperine-PNL capsule

EXPERIMENTAL

12 volunteers will receive a single oral dose of THC:CBD P-PNL capsule with 200 mL of water. The dose of THC and CBD to be administered is the same as in the Sativex arm: THC 21.6 mg and CBD 20 mg.

Drug: CBD-THC-Piperine-PNL capsule

Interventions

Sativex buccal sprayDRUG

buccal spray

Also known as: Sativex
Sativex buccal spray
CBD-THC-Piperine-PNL capsuleDRUG

a capsule containing Cannabidiol and Tetrahydrocannabinol combination

Also known as: Cannabidiol and dronabinol in ProNanoLiposphere formulation
CBD-THC-Piperine-PNL capsule

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men 18 through 45 years of age
  • Body mass index in the range of: 25 through 30 kg/m2.
  • Participants must be able to swallow and absorb oral medications.
  • Normal Values Vital Sign Parameters as following: systolic blood pressure 90-139 mmHg, diastolic blood pressure 50-89 mmHg, pulse rate 45-100 bpm, body temperature 36.0-37.5º C.
  • Subjects must be able to understand and comply with the requirements of the study (e.g. all medication, dietary, and alcohol restrictions).
  • Subjects must provide written informed consent to participate in the study after reading the information and consent form, and after having an opportunity to discuss the study with the investigator.
  • Subjects must complete the screening process within 4 weeks prior to the admission visit.

You may not qualify if:

  • Previous participation in an investigational trial involving administration of any investigational compounds within two month prior to the current study.
  • Impaired glucose tolerance
  • Diabetes mellitus
  • Renal disease
  • Edema
  • Stroke or neurological disorder
  • Arthritis, joint or tendon abnormalities
  • History of asthma
  • Hepatic disorder
  • History of seizures
  • History of psychosis any addictive or other psychiatric disease disorder or a history of any illness that,might confound the results of the study or pose risk by participation in the study.
  • History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 or 2.
  • History of cannabis intoxication or dependence.
  • Use of the forbidden drugs, substances or foods as follows:
  • Investigational product (THC or/and CBD ingestion or smoking) within one month preceding the study.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah medical organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

nabiximolsCannabidiolDronabinol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Elyad Davidson, MD

    Director of the pain relief unit in Hadassah Hebrew University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2013

First Posted

July 9, 2013

Study Start

August 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

March 24, 2016

Record last verified: 2016-03

Locations

IL(1)