Clinical trial NCT01015040: Relative Bioavailability Study of Solifenacin Succinate Liquid Suspension (Fed and Fasting) Versus VESIcare Tablet (Fasting) in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability of Solifenacin Succinate
Pharmacokinetics of Solifenacin Succinate
Healthy Volunteers
Keywords: solifenacin succinate
VESIcare
Healthy Volunteers
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-11-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum solifenacin succinate pharmacokinetics (PK) parameters
timeFrame: Periods 1, 2 and 3 Days 1-11
Secondary outcomes:
Other outcomes:
Locations:
city: West Bend
country: United States
state: Wisconsin
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_DIRECTOR
References: