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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01015040
First received: November 16, 2009
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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


Condition Intervention Phase
Bioavailability of Solifenacin Succinate
Pharmacokinetics of Solifenacin Succinate
Healthy Volunteers
Drug: solifenacin succinate suspension
Drug: solifenacin succinate tablet
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Serum solifenacin succinate pharmacokinetics (PK) parameters [ Time Frame: Periods 1, 2 and 3 Days 1-11 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: solifenacin succinate tablet (fasting)
N/A
Drug: solifenacin succinate tablet
Oral
Other Names:
  • VESIcare
  • YM905
Experimental: solifenacin succinate suspension (fasting)
N/A
Drug: solifenacin succinate suspension
Oral
Other Name: YM905
Experimental: solifenacin succinate suspension (fed)
N/A
Drug: solifenacin succinate suspension
Oral
Other Name: YM905

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015040

Locations
United States, Wisconsin
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Sr. Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01015040     History of Changes
Other Study ID Numbers: 905-CL-066
Study First Received: November 16, 2009
Last Updated: December 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
solifenacin succinate
VESIcare
Healthy Volunteers

Additional relevant MeSH terms:
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014