Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-03-13 @ 9:55 AM
Study NCT ID:
NCT05416957
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2022-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effect Bioavailability Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
Sponsor:
Seasons Biotechnology (Taizhou) Co., Ltd.
Organization:
Study Overview
Official Title:
Single Dose Oral Food Effect Bioavailability Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg in Healthy Adult Human Subjects Under Fasting and Fed Conditions
Status:
COMPLETED
Status Verified Date:
2023-04
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:
An open label, randomized, two-period, two-treatment \[Treatment A (Investigational product administration under fasting condition) vs Treatment B (Investigational product administration under fed condition)\], two-sequence, crossover, balanced, single dose oral food effect bioavailability study.
Detailed Description:
Single dose oral food effect bioavailability study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg in healthy adult human subjects under fasting and fed conditions.
* To compare and evaluate the oral bioavailability of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg in healthy, adult, human subjects under fasting and fed conditions.
* To monitor the safety and tolerability of the subjects. An open label, randomized, two-period, two-treatment \[Treatment A (Investigational product administration under fasting condition) vs Treatment B (Investigational product administration under fed condition)\], two-sequence, crossover, balanced, single dose oral food effect bioavailability study.
* To compare and evaluate the oral bioavailability of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg in healthy, adult, human subjects under fasting and fed conditions.
* To monitor the safety and tolerability of the subjects. An open label, randomized, two-period, two-treatment \[Treatment A (Investigational product administration under fasting condition) vs Treatment B (Investigational product administration under fed condition)\], two-sequence, crossover, balanced, single dose oral food effect bioavailability study.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?: