Overview
Cannabidiol - an in Vivo Innovative Drug Delivery Study
Status:
Terminated
Terminated
Trial end date:
2019-08-29
2019-08-29
Target enrollment:
0
0
Participant gender:
All
All
Summary
Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Central Institute of Mental Health, MannheimTreatments:
Cannabidiol
Criteria
Inclusion Criteria:- 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 Criteria:
- 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