The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A
NCT05049733 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2023-06-07
Summary
The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio.
Conditions
- Cannabis
Interventions
- DRUG
-
CBD 1mg/Kg
Participants will ingest soft gel tablets containing CBD 1mg/Kg
- DRUG
-
CBD 2mg/Kg
Participants will ingest soft gel tablets containing CBD 2mg/Kg
- DRUG
-
CBD 4mg/Kg
Participants will ingest soft gel tablets containing CBD 4mg/Kg
- DRUG
-
Placebo CBD
Participants will ingest soft gel tablets containing placebo for CBD
Sponsors & Collaborators
-
Cultivate Biologics
collaborator UNKNOWN - lead OTHER
Principal Investigators
-
Tory Spindle, PhD · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-03-07
- Primary Completion
- 2023-06-01
- Completion
- 2023-06-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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