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Two step study, step two was not feasible based on results from phase one.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference formulation | Active Comparator | Cannabidiol capsule, 200 mg |
|
| New formulation | Experimental | Cannabidiol, intranasal gel (XX mg, dose need to be determined during the study) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | single or multiple dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-∞)) | reference formulation compared to new formulation | 36 hours |
| Pharmacokinetic profile of single dose - residual area | reference formulation compared to new formulation | 36 hours |
| Pharmacokinetic profile of single dose - maximum concentration (Cmax) | reference formulation compared to new formulation | 36 hours |
| Pharmacokinetic profile of single dose - time to reach Cmax (tmax) | reference formulation compared to new formulation | 36 hours |
| Pharmacokinetic profile of single dose - elimination half life (t1/2) | reference formulation compared to new formulation | 36 hours |
| Pharmacokinetic profile of single dose - elimination rate constant (λz) | reference formulation compared to new formulation | 36 hours |
| Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ)) | reference formulation compared to new formulation | 9 days |
| Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss) |
| Measure | Description | Time Frame |
|---|---|---|
| Regular laboratory testing | standard laboratory blood tests | 36h or 9 days |
| Electrocardiography - QTc time | 36 hours or 9 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Fuhr, MD | Department I of Pharmacology, University of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department I of Pharmacology, University of Cologne | Cologne | 50931 | Germany |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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reference formulation compared to new formulation |
| 9 days |
| Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss) | reference formulation compared to new formulation | 9 days |
| Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (τ=12h)) | reference formulation compared to new formulation | 9 days |
| Pharmacokinetic profile of multiple dosing - steady state accumulation ratio | reference formulation compared to new formulation | 9 days |
| Vital signs - body temperature |
| 36 hours or 9 days |
| Vital signs - blood pressure | Systolic and diastolic blood pressure reported in millimetres of mercury (mmHg) | 36 hours or 9 days |
| Vital signs - pulse rate | 36 hours or 9 days |