Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-02-01 @ 9:34 AM
Study NCT ID:
NCT02604992
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2015-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers
Sponsor:
INSYS Therapeutics Inc
Organization:
Study Overview
Official Title:
An Open-Label, Randomized, Single-Dose, Two-Period, Two-Way Crossover Comparative Bioavailability Study of Dronabinol Oral Solution, 4.25 mg to Marinol Capsule, 5 mg in Healthy Volunteers Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2016-01
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:
The primary objective of this study is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (RLD) administered to participants under fed and fasted conditions.
The secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.
The secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: