Healthy Volunteers Clinical Trial
Official title:
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
A study in healthy volunteers comparing two different liquid formulations of solifenacin with each other and with the tablet formulation.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
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