Cannabidiol - an in Vivo Innovative Drug Delivery Study

Central Institute of Mental Health, Mannheim

Status and phase

Terminated

Phase 1

Conditions

Pharmacokinetics, Bioavailability

Treatments

Drug: Cannabidiol

Study type

Interventional

Funder types

Other

Identifiers

NCT03471559

CBD-DDS

Details and patient eligibility

About

Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.

Full description

This study aims to investigate an innovative pharmaceutical preparation of cannabidiol. Thus, a comparative bioavailability study will be conducted, comparing cannabidiol capsules (reference formulation) with an intranasal cannabidiol gel (test formulation), with the further aim to find an appropriate dosing of the new pharmaceutical preparation. The intranasal administration may also be suitable to reduce the high variability in the bioavailability of cannabidiol observed for the current oral administration.

Enrollment

8 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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