Pharmacokinetics, Bioavailability
Conditions
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 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.
Interventions
DRUGCannabidiol
single or multiple dosing
Sponsors
Central Institute of Mental Health, Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profile of multiple dosing - steady state accumulation ratio | 9 days | reference formulation compared to new formulation |
| Pharmacokinetic profile of single dose - elimination rate constant (λz) | 36 hours | reference formulation compared to new formulation |
| Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ)) | 9 days | reference formulation compared to new formulation |
| Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss) | 9 days | reference formulation compared to new formulation |
| Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss) | 9 days | reference formulation compared to new formulation |
| Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (τ=12h)) | 9 days | reference formulation compared to new formulation |
| Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-∞)) | 36 hours | reference formulation compared to new formulation |
| Pharmacokinetic profile of single dose - residual area | 36 hours | reference formulation compared to new formulation |
| Pharmacokinetic profile of single dose - maximum concentration (Cmax) | 36 hours | reference formulation compared to new formulation |
| Pharmacokinetic profile of single dose - time to reach Cmax (tmax) | 36 hours | reference formulation compared to new formulation |
| Pharmacokinetic profile of single dose - elimination half life (t1/2) | 36 hours | reference formulation compared to new formulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiography - QTc time | 36 hours or 9 days | — |
| Vital signs - body temperature | 36 hours or 9 days | — |
| Vital signs - blood pressure | 36 hours or 9 days | Systolic and diastolic blood pressure reported in millimetres of mercury (mmHg) |
| Vital signs - pulse rate | 36 hours or 9 days | — |
| Regular laboratory testing | 36h or 9 days | standard laboratory blood tests |
Countries
Germany
Outcome results
None listed