Pharmacokinetics, Bioavailability Clinical Trial
Official title:
Cannabidiol as a Medication for Neuropsychiatric and Other Medical Conditions - an in Vivo Innovative Drug Delivery Study
Verified date | June 2020 |
Source | Central Institute of Mental Health, Mannheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.
Status | Terminated |
Enrollment | 8 |
Est. completion date | August 29, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department I of Pharmacology, University of Cologne | Cologne |
Lead Sponsor | Collaborator |
---|---|
Central Institute of Mental Health, Mannheim |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-8)) | reference formulation compared to new formulation | 36 hours | |
Primary | Pharmacokinetic profile of single dose - residual area | reference formulation compared to new formulation | 36 hours | |
Primary | Pharmacokinetic profile of single dose - maximum concentration (Cmax) | reference formulation compared to new formulation | 36 hours | |
Primary | Pharmacokinetic profile of single dose - time to reach Cmax (tmax) | reference formulation compared to new formulation | 36 hours | |
Primary | Pharmacokinetic profile of single dose - elimination half life (t1/2) | reference formulation compared to new formulation | 36 hours | |
Primary | Pharmacokinetic profile of single dose - elimination rate constant (?z) | reference formulation compared to new formulation | 36 hours | |
Primary | Pharmacokinetic profile of multiple dosing - area under the curve (AUC(t)) | reference formulation compared to new formulation | 9 days | |
Primary | Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss) | reference formulation compared to new formulation | 9 days | |
Primary | Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss) | reference formulation compared to new formulation | 9 days | |
Primary | Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (t=12h)) | reference formulation compared to new formulation | 9 days | |
Primary | Pharmacokinetic profile of multiple dosing - steady state accumulation ratio | reference formulation compared to new formulation | 9 days | |
Secondary | Regular laboratory testing | standard laboratory blood tests | 36h or 9 days | |
Secondary | Electrocardiography - QTc time | 36 hours or 9 days | ||
Secondary | Vital signs - body temperature | 36 hours or 9 days | ||
Secondary | Vital signs - blood pressure | Systolic and diastolic blood pressure reported in millimetres of mercury (mmHg) | 36 hours or 9 days | |
Secondary | Vital signs - pulse rate | 36 hours or 9 days |