Ignite Creation Date:
2025-12-18 @ 7:13 AM
Ignite Modification Date:
2025-12-23 @ 8:46 PM
Study NCT ID:
NCT00749879
Status:
None
Last Update Posted:
2019-04-29 00:00:00
First Post:
2008-09-05 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Crossover Study of the Safety and PK Properties of Proellex®
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase I, Open-Label, Randomized, Single-Center, Unblinded, Single-Dose, Five-Way Crossover Study of the Safety and PK Properties of Proellex®
Status:
None
Status Verified Date:
2019-01
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:
This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50 mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers in the fed and fasting states.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: