Relative Bioavailability Study of Solifenacin Succinate Liquid Suspension (Fed and Fasting) Versus VESIcare Tablet (Fasting) in Healthy Volunteers

Study Overview
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Brief Summary
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The objective of the study is to compare the relative bioavailability and pharmacokinetics of solifenacin succinate suspension versus tablet.

Detailed Description
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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.

Official Title
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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

Conditions
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Bioavailability of Solifenacin Succinate, Pharmacokinetics of Solifenacin Succinate, Healthy Volunteers

Intervention / Treatment
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* Drug: solifenacin succinate suspension
* Drug: solifenacin succinate tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subject weighing at least 45 kg with a Body Mass Index (BMI) of 18-32 kg/m2, inclusive If female, subject is at least 2 years postmenopausal, surgically sterile or practicing effective birth control and is not lactating or pregnant Medically healthy, with a normal 12-lead electrocardiogram (ECG) Good venous access in both arms Exclusion Criteria: History of any clinically significant disease or malignancy excluding non-melanoma skin cancer Known hypersensitivity to VESIcare® or any of the excipients in the formulations, or a history of severe allergic or anaphylactic reactions History of alcoholism or substance abuse within past 2 years Has used tobacco-containing products and nicotine or nicotine containing products within six months Supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or pulse rate < 40 or > 100 beats per minute Positive test for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg) Known positive for human immunodeficiency virus (HIV) antibody Clinical laboratory tests outside the normal limits Treatment with prescription or non-prescription drugs, including complementary and alternative medicines or over-the-counter medications, with the exception of oral contraceptives, hormone replacement therapy, and occasional use of acetaminophen within 14 days prior to Day 1 Inability to abstain from alcohol or caffeine use for 48 hours prior to the administration of the first dose of study drug and throughout the duration of the study or from grapefruit, Seville oranges, star fruit, or any products containing these items from 72 hours prior to the administration of the first dose of study drug and throughout the duration of the study Donated one unit of blood or more, has had significant blood loss, or received a transfusion of any blood or blood products within 60 days or has donated plasma within 7 days prior to study check-in Any clinically significant history of gastrointestinal symptoms such as nausea, abdominal discomfort or upset, or heartburn in the four weeks prior to study check-in or a history of any gastrointestinal surgery except for appendectomy or cholecystectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: solifenacin succinate tablet (fasting)<br> | Drug: solifenacin succinate tablet<br>* Oral<br>* Other names: YM905;|
| Experimental: solifenacin succinate suspension (fasting)<br> | Drug: solifenacin succinate suspension<br>* Oral<br>* Other names: YM905;|
| Experimental: solifenacin succinate suspension (fed)<br> | Drug: solifenacin succinate suspension<br>* Oral<br>* Other names: YM905;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum solifenacin succinate pharmacokinetics (PK) parameters |  | Periods 1, 2 and 3 Days 1-11 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solifenacin succinate, VESIcare, Healthy Volunteers