Overview

Cannabidiol - an in Vivo Innovative Drug Delivery Study

Status:
Terminated
Trial end date:
2019-08-29
Target enrollment:
0
Participant gender:
All
Summary
Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Central Institute of Mental Health, Mannheim
Treatments:
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