Status:
TERMINATED
Cannabidiol - an in Vivo Innovative Drug Delivery Study
Lead Sponsor:
Central Institute of Mental Health, Mannheim
Conditions:
Pharmacokinetics, Bioavailability
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.
Detailed Description
This study aims to investigate an innovative pharmaceutical preparation of cannabidiol. Thus, a comparative bioavailability study will be conducted, comparing cannabidiol capsules (reference formulati...
Eligibility Criteria
Inclusion
- Informed consent given by the subject
- Negative drug screening at the time of screening
- Non-smoking
- In female participants in fertile age, reliable contraception, which means contraception's Pearl index is equal to or smaller than 1.
- Body Mass Index between 18.5 kg/m2 and 30 kg/m2
Exclusion
- Lack of accountability
- Pregnancy or lactation phase in females at the time of screening
- Any known psychiatric or neurological illness in the participant's history.
- Known family history regarding psychiatric disorders with an increased lifetime risk for psychiatric disorders in the participant (investigators qualified judgement)
- Relevant use of cannabis (which is defined on the present state of knowledge as more than five times lifetime consumption and/or more than two consumptions during the last year)
- Consumption of any illicit drugs (except cannabis in history, see above)
- Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematologic or endocrinologic disorders or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, as assessed by the investigator
Key Trial Info
Start Date :
December 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03471559
Start Date
December 10 2018
End Date
August 29 2019
Last Update
July 1 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department I of Pharmacology, University of Cologne
Cologne, Germany, 50931