Status:
COMPLETED
CBD Cannabis Extract: Pharmacokinetic Studies
Lead Sponsor:
University of Mississippi, Oxford
Conditions:
Epilepsy
Eligibility:
All Genders
21-55 years
Phase:
EARLY_PHASE1
Brief Summary
The initial goal is to ascertain the pharmacokinetic (PK) profile of CBD (cannabidiol) after a single dose of CBDE (cannabidiol extract), although the plan is to extend these studies to multiple dose ...
Detailed Description
The objective is to determine the PK profile of CBD(cannabidiol) , its metabolites, and minor phytocannabinoids after single dose administration of CBDE (at 2.5 mg/kg CBD). Attainment of this goal wil...
Eligibility Criteria
Inclusion
- Normal, healthy adults aged 21 to 55 years
Exclusion
- Allergy to sesame oil/products
- Obese: BMI is 35 or higher
- Smoker (tobacco \& marijuana use \[smoking or use of oral hemp/CBD products\])
- Currently any taking prescriptions medication(s) \[with exception of oral contraceptives\] or over-the-counter medications/supplements
- Consuming botanical/non-botanical dietary supplements (3 days prior to study)
- Known history of cardiac, liver, kidney or hematological disease, diabetes
- Autoimmune disorders
- Known history of Neurologic/Psychiatric disorders
- Report of an active infection
- Subject is pregnant or breast-feeding, or is expecting to conceive during the study
- Subjects of child bearing potential will use (or is currently using) during the study, one of the following acceptable methods of contraception:
- Male sterilization (vasectomy) Female sterilization (tubal ligation, hysterectomy) Intrauterine service intrauterine device (IUD) or other implant Oral contraceptive, injectable contraceptive Contraceptive patch/ring Diaphragm Male condom Sponge/spermicide
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04280289
Start Date
February 1 2021
End Date
December 1 2021
Last Update
November 20 2024
Active Locations (1)
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1
University of Mississippi
University, Mississippi, United States, 38677