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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bioavailability of Solifenacin Succinate; Pharmacokinetics of Solifenacin Succinate; Healthy Volunteers

Intervention: solifenacin succinate suspension (Drug); solifenacin succinate tablet (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma Global Development


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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Serum solifenacin succinate pharmacokinetics (PK) parameters

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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- Healthy subject weighing at least 45 kg with a Body Mass Index (BMI) of 18-32 kg/m2,


- 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


- 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

Locations and Contacts

West Bend, Wisconsin 53095, United States
Additional Information

Starting date: September 2009
Last updated: December 4, 2009

Page last updated: August 23, 2015

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