Trials / Completed
CompletedNCT01015040
Relative Bioavailability Study of Solifenacin Succinate Liquid Suspension (Fed and Fasting) Versus VESIcare Tablet (Fasting) in Healthy Volunteers
A Phase 1, Open-Label, Randomized, Single Dose, 3-Way Crossover Study to Address the Relative Bioavailability of Solifenacin Liquid Suspension 10mg (Fed and Fasting) Versus the VESIcare (Solifenacin Succinate) 10 mg Tablet (Fasting) in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The objective of the study is to compare the relative bioavailability and pharmacokinetics of solifenacin succinate suspension versus tablet.
Detailed description
All subjects will participate in each treatment separated by a minimum (=\> minimum) of 13 days between dosing. In the two fasting periods, each subject will receive solifenacin succinate orally in each treatment period following a minimum 10 hour fast from food and beverages. In the fed condition, each subject will receive the suspension within 30 minutes of the start of breakfast.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | solifenacin succinate suspension | Oral |
| DRUG | solifenacin succinate tablet | Oral |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2009-11-01
- Completion
- 2009-11-01
- First posted
- 2009-11-17
- Last updated
- 2009-12-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01015040. Inclusion in this directory is not an endorsement.