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

Phase 1

Completed

• Conditions: Bioavailability of Solifenacin Succinate; Pharmacokinetics of Solifenacin Succinate; Healthy Volunteers
• Interventions: Drug: solifenacin succinate tablet; Drug: solifenacin succinate suspension

• Registration Number: NCT01015040
• Lead Sponsor: Astellas Pharma Inc

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
solifenacin succinate tablet (fasting)	solifenacin succinate tablet	-
solifenacin succinate suspension (fasting)	solifenacin succinate suspension	-
solifenacin succinate suspension (fed)	solifenacin succinate suspension	-

Primary Outcome Measures

Name	Time	Method
Serum solifenacin succinate pharmacokinetics (PK) parameters	Periods 1, 2 and 3 Days 1-11