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

NCT01015040 | Completed Phase 1

• 1 other identifier: 905-CL-066
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bioavailability of Solifenacin Succinate; Pharmacokinetics of Solifenacin Succinate; Healthy Volunteers

Keywords

solifenacin succinate; VESIcare; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Serum solifenacin succinate pharmacokinetics (PK) parameters

  Periods 1, 2 and 3 Days 1-11

Study Arms (3)

solifenacin succinate tablet (fasting)

ACTIVE COMPARATOR

Drug: solifenacin succinate tablet

solifenacin succinate suspension (fasting)

EXPERIMENTAL

Drug: solifenacin succinate suspension

solifenacin succinate suspension (fed)

EXPERIMENTAL

Drug: solifenacin succinate suspension

Interventions

solifenacin succinate suspension DRUG

Oral

Also known as: YM905

solifenacin succinate suspension (fasting); solifenacin succinate suspension (fed)

solifenacin succinate tablet DRUG

Oral

Also known as: VESIcare, YM905

solifenacin succinate tablet (fasting)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

Solifenacin Succinate

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Use Central Contact

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

US (1)