Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-28 @ 5:14 PM
Study NCT ID:
NCT04261166
Status:
COMPLETED
Last Update Posted:
2022-12-08
First Post:
2020-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract
Sponsor:
Breath of Life International Pharma Ltd
Organization:
Study Overview
Official Title:
A Phase I Open Label Study to Assess the Single Dose Pharmacokinetics and Safety of Sublingual Administration of Tablets and Medicated Drops of Plant Cannabis Extract
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration.
Detailed Description:
None
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?: