Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04478357
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2020-07-01
Brief Title:
BIOEQUIVALENCE STUDY IN HEALTHY PARTICIPANTS COMPARING 4 MG AND 8 MG FESOTERODINE EXTENDED-RELEASE TABLETS TOVIAZ MANUFACTURED AT ZWICKAU VERSUS FREIBURG
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
AN OPEN-LABEL RANDOMIZED SINGLE-DOSE 4 PERIOD 4 TREATMENT 2 SEQUENCE TWO 2 WAY CROSSOVER BIOEQUIVALENCE STUDY IN HEALTHY PARTICIPANTS COMPARING 4 MG AND 8 MG FESOTERODINE EXTENDED RELEASE TABLETS TOVIAZTM MANUFACTURED AT ZWICKAU VERSUS FREIBURG
Status:
COMPLETED
Status Verified Date:
2021-05
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:
Fesoterodine Toviaz extended-release ER tablets are currently manufactured by Aesica Pharmaceuticals Zwickau Germany Zwickau An additional manufacturing location at Pfizer Freiburg Germany Freiburg has been identified This pivotal bioequivalence BE study is being conducted to satisfy the United States US Food and Drug Administration FDA regulatory requirements for the qualification of the Freiburg manufacturing site
Overall Study Design This is an open-label randomized single-dose 4-period 4-treatment 2-sequence two 2-way crossover study in healthy participants This study will assess the BE of Fesoterodine Toviaz 4 mg and 8 mg ER tablets manufactured at Zwickau Reference versus Freiburg Test Study participants will include healthy male andor female individuals between the ages of 18 and 55 years inclusive Approximately 18 participants who fulfill entry criteria will be randomized to 1 of the 2 treatment sequences as shown in the table below
Overall Study Design This is an open-label randomized single-dose 4-period 4-treatment 2-sequence two 2-way crossover study in healthy participants This study will assess the BE of Fesoterodine Toviaz 4 mg and 8 mg ER tablets manufactured at Zwickau Reference versus Freiburg Test Study participants will include healthy male andor female individuals between the ages of 18 and 55 years inclusive Approximately 18 participants who fulfill entry criteria will be randomized to 1 of the 2 treatment sequences as shown in the table below
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-002783-32 | EUDRACT_NUMBER | None | None |