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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015040
• Other study ID #: 905-CL-066
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2009
• Last updated: December 4, 2009
• Start date: September 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2009
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bioavailability of Solifenacin Succinate
• Healthy Volunteers
• Pharmacokinetics of Solifenacin Succinate

Intervention

Drug:
• solifenacin succinate suspension
Oral
• solifenacin succinate tablet
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum solifenacin succinate pharmacokinetics (PK) parameters		Periods 1, 2 and 3 Days 1-11	No