Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04686669
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2020-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations
Sponsor:
Forendo Pharma Ltd
Organization:
Study Overview
Official Title:
A Phase 1, Randomised, Open-Label, Three-way, Three-period, Crossover Relative Bioavailability Study to Assess the Single-Dose Pharmacokinetics of FOR-6219 in Capsule and Tablet Formulations in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2021-01
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 is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the single-dose pharmacokinetics of FOR-6219 in capsule and tablet formulations in postmenopausal women. The effect of high-fat food on the pharmacokinetics of the tablet formulation will also be evaluated. A total of twelve, post-menopausal women, will be randomised to receive a single oral dose of FOR-6219 in three treatment periods: capsule formulation (fasted); tablet formulation (fed); tablet formulation (fasted)
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?: