Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03729284
Status:
WITHDRAWN
Last Update Posted:
2019-10-04
First Post:
2018-10-16
Brief Title:
A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE IV SINGLE-DOSE OPEN-LABEL RANDOMIZED 2-WAY CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF DULOXETINE HYDROCHLORIDE HARD GELATINOUS CAPSULE WITH DELAYED RELEASE MICROGRANULES 60 MG PFIZER SRL - ARGENTINA COMPARED WITH CYMBALTAREGISTERED 60 MG ELI LILLY DO BRASIL LTDA IN HEALTHY MALE RESEARCH SUBJECTS UNDER FASTED CONDITIONS
Status:
WITHDRAWN
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study has been cancelled prior to FSFV due to business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Brazil duloxetine is currently available as hard gelatinous capsule with delayed release microgranules for oral administration containing enteric-coated pellets of 337 or 673 mg of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine Cymbalta respectively
The Sponsor has developed a hard gelatinous capsule with delayed release microgranules formulation containing enteric-coated pellets of 337 or 673 mg of duloxetine hydrochloride equivalent to 30 or 60 mg of duloxetine respectively
The purpose of this study is to verify through a single dose study if the test formulation of duloxetine 60 mg is bioequivalent to the reference formulation Cymbalta 60 mg when administered with the same dosage and under fasted conditions in healthy male research subjects
The Sponsor has developed a hard gelatinous capsule with delayed release microgranules formulation containing enteric-coated pellets of 337 or 673 mg of duloxetine hydrochloride equivalent to 30 or 60 mg of duloxetine respectively
The purpose of this study is to verify through a single dose study if the test formulation of duloxetine 60 mg is bioequivalent to the reference formulation Cymbalta 60 mg when administered with the same dosage and under fasted conditions in healthy male research subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None