Bioavailability of Solifenacin SuccinatePhase 1NCT01015040
Relative Bioavailability Study of Solifenacin Succinate Liquid Suspension (Fed and Fasting) Versus VESIcare Tablet (Fasting) in Healthy Volunteers
A Phase 1 study testing solifenacin succinate suspension and solifenacin succinate tablet in people with Bioavailability of Solifenacin Succinate and Pharmacokinetics of Solifenacin Succinate, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
The objective of the study is to compare the relative bioavailability and pharmacokinetics of solifenacin succinate suspension versus tablet. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability of Solifenacin Succinate, Pharmacokinetics of Solifenacin Succinate, Healthy Volunteers
- What is being tested?
- solifenacin succinate suspension and solifenacin succinate tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The objective of the study is to compare the relative bioavailability and pharmacokinetics of solifenacin succinate suspension versus tablet.
Read the 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.
- Conditions
- Bioavailability of Solifenacin Succinate, Pharmacokinetics of Solifenacin Succinate, Healthy Volunteers
- Being tested
- solifenacin succinate suspension, solifenacin succinate tablet
- Keywords
- solifenacin succinate, VESIcare, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacin succinate suspensionDrug
Also called YM905
Oral
solifenacin succinate tabletDrug
Also called VESIcare, YM905
Oral
| Study group | Role | What they receive |
|---|---|---|
| solifenacin succinate tablet (fasting) | Active comparator | Not described Receives: Drug: solifenacin succinate tablet |
| solifenacin succinate suspension (fasting) | Experimental | Not described Receives: Drug: solifenacin succinate suspension |
| solifenacin succinate suspension (fed) | Experimental | Not described Receives: Drug: solifenacin succinate suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum solifenacin succinate pharmacokinetics (PK) parameters
Measured: Periods 1, 2 and 3 Days 1-11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability of Solifenacin SuccinateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015040
- Sponsor's protocol ID
- 905-CL-066
- Status last verified
- Dec 2009
- First submitted
- 16 Nov 2009
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01015040
- Acronym / sponsor ID
- 905-CL-066
- Conditions
- Bioavailability of Solifenacin Succinate, Pharmacokinetics of Solifenacin Succinate, Healthy Volunteers
- Keywords
- solifenacin succinate, VESIcare, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| solifenacin succinate suspensionAlso: YM905Oral | Drug | solifenacin succinate suspension (fasting), solifenacin succinate suspension (fed) |
| solifenacin succinate tabletAlso: VESIcare, YM905Oral | Drug | solifenacin succinate tablet (fasting) |
Primary outcome
Serum solifenacin succinate pharmacokinetics (PK) parameters
Time frame: Periods 1, 2 and 3 Days 1-11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use Central Contact study director
Astellas Pharma Global Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing solifenacin succinate suspension and solifenacin succinate tablet in people with Bioavailability of Solifenacin Succinate and Pharmacokinetics of Solifenacin Succinate, run by Astellas Pharma Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum solifenacin succinate pharmacokinetics (PK) parameters (time frame: Periods 1, 2 and 3 Days 1-11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2009.