Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
single or multiple dosing
Department I of Pharmacology, University of Cologne
Cologne, Germany
Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-∞))
reference formulation compared to new formulation
Time frame: 36 hours
Pharmacokinetic profile of single dose - residual area
reference formulation compared to new formulation
Time frame: 36 hours
Pharmacokinetic profile of single dose - maximum concentration (Cmax)
reference formulation compared to new formulation
Time frame: 36 hours
Pharmacokinetic profile of single dose - time to reach Cmax (tmax)
reference formulation compared to new formulation
Time frame: 36 hours
Pharmacokinetic profile of single dose - elimination half life (t1/2)
reference formulation compared to new formulation
Time frame: 36 hours
Pharmacokinetic profile of single dose - elimination rate constant (λz)
reference formulation compared to new formulation
Time frame: 36 hours
Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ))
reference formulation compared to new formulation
Time frame: 9 days
Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss)
reference formulation compared to new formulation
Time frame: 9 days
Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss)
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reference formulation compared to new formulation
Time frame: 9 days
Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (τ=12h))
reference formulation compared to new formulation
Time frame: 9 days
Pharmacokinetic profile of multiple dosing - steady state accumulation ratio
reference formulation compared to new formulation
Time frame: 9 days
Regular laboratory testing
standard laboratory blood tests
Time frame: 36h or 9 days
Electrocardiography - QTc time
Time frame: 36 hours or 9 days
Vital signs - body temperature
Time frame: 36 hours or 9 days
Vital signs - blood pressure
Systolic and diastolic blood pressure reported in millimetres of mercury (mmHg)
Time frame: 36 hours or 9 days
Vital signs - pulse rate
Time frame: 36 hours or 9 days