Trials / Completed
CompletedNCT04478357
BIOEQUIVALENCE STUDY IN HEALTHY PARTICIPANTS COMPARING 4 MG AND 8 MG FESOTERODINE EXTENDED-RELEASE TABLETS (TOVIAZ™), MANUFACTURED AT ZWICKAU VERSUS FREIBURG
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 (TOVIAZ(TM)), MANUFACTURED AT ZWICKAU VERSUS FREIBURG
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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 and/or 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 4 mg Fesoterodine ER tablet from Zwickau | Manufactured at Zwickau |
| DRUG | 4 mg fesoterodine ER tablet from Freiburg | Manufactured at Freiburg |
| DRUG | 8 mg fesoterodine ER tablet from Zwickau | Manufactured at Zwickau |
| DRUG | 8 mg fesoterodine ER tablet from Freiburg | Manufactured at Freiburg |
Timeline
- Start date
- 2019-11-12
- Primary completion
- 2020-11-12
- Completion
- 2020-11-12
- First posted
- 2020-07-20
- Last updated
- 2021-05-07
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04478357. Inclusion in this directory is not an endorsement.