NCT01406158

A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation

A Phase 1, Open-Label, Randomized, Single Dose, 3-Way Crossover Study to Assess the Relative Bioavailability of Solifenacin Liquid Suspension 10 mg (Formulation B) Versus Solifenacin Liquid Suspension 10 mg (Formulation A) and to Assess the Relative Bioavailability of Solifenacin Liquid Suspension 10 mg (Formulation A and B) Versus the VESIcare (Solifenacin Succinate) 10 mg Tablet 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

A study in healthy volunteers comparing two different liquid formulations of solifenacin with each other and with the tablet formulation.

Detailed description

Subjects will be randomized to one of six treatment sequences. The treatments will be separated by a minimum of 13 days between dosing. Study drug will be administered after an overnight fast, and food will be restricted for an additional four hours after dosing. Except for the water provided with dosing, water will be restricted only during the hour before and the hour after dosing. Subjects will stay at the study site for the first three days of each treatment period. Subjects will return to the study center each morning at the same time of the day for Days 4 through 11 of each study period for the pharmacokinetic blood draw and vital signs. Subjects will be in the study for at least 40 days.

Conditions

• Pharmacokinetics of Solifenacin Succinate
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Solifenacin Succinate Formulation A	oral suspension
DRUG	Solifenacin Succinate Formulation B	oral suspension
DRUG	Solifenacin Succinate	oral tablet

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-08-01
• Last updated: 2011-08-24

Locations

1 site across 1 country: United States