Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT00939835
Status:
COMPLETED
Last Update Posted:
2017-10-24
First Post:
2009-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects in Fed Condition
Sponsor:
Torrent Pharmaceuticals Limited
Organization:
Study Overview
Official Title:
A Randomized, Single Dose, Open Label, Bioequivalence Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects in Fed Condition
Status:
COMPLETED
Status Verified Date:
2017-10
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:
* Objective:
* The objective of this study is to compare the rate and extent of absorption of the Test Product, Citalopram Hydrobromide 40 mg (Torrent Pharmaceutical Limited) to the Reference Product, RLD Tablets 40 mg (Forest Pharmaceuticals Inc, Missouri) under fed condition
* Study Design:
* Randomized, Single Dose, Open Label, Non-Replicate, Two-period, Two-treatment, Two- Sequence Crossover Bioequivalence Study comparing Citalopram Hydrobromide Tablets 40 mg (manufactured by Torrent Pharmaceuticals Ltd). With RLD Tablets 40 mg (manufactured by Forest Pharmaceuticals Inc Missouri) in 24+2 normal healthy male subjects with a wash out period of 15 days between the two study periods, in fed condition.
* The objective of this study is to compare the rate and extent of absorption of the Test Product, Citalopram Hydrobromide 40 mg (Torrent Pharmaceutical Limited) to the Reference Product, RLD Tablets 40 mg (Forest Pharmaceuticals Inc, Missouri) under fed condition
* Study Design:
* Randomized, Single Dose, Open Label, Non-Replicate, Two-period, Two-treatment, Two- Sequence Crossover Bioequivalence Study comparing Citalopram Hydrobromide Tablets 40 mg (manufactured by Torrent Pharmaceuticals Ltd). With RLD Tablets 40 mg (manufactured by Forest Pharmaceuticals Inc Missouri) in 24+2 normal healthy male subjects with a wash out period of 15 days between the two study periods, in fed condition.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: