Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-02 @ 11:38 AM
Study NCT ID:
NCT03471559
Status:
TERMINATED
Last Update Posted:
2020-07-01
First Post:
2018-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabidiol - an in Vivo Innovative Drug Delivery Study
Sponsor:
Central Institute of Mental Health, Mannheim
Organization:
Study Overview
Official Title:
Cannabidiol as a Medication for Neuropsychiatric and Other Medical Conditions - an in Vivo Innovative Drug Delivery Study
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Two step study, step two was not feasible based on results from phase one.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: