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