A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation
Tracking Information | |||||
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First Received Date ICMJE | July 14, 2011 | ||||
Last Updated Date | August 23, 2011 | ||||
Start Date ICMJE | May 2011 | ||||
Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Pharmacokinetic assessment of AUC and maximum concentration (Cmax) through the analysis of blood samples [ Time Frame: Up to Day 11 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01406158 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation | ||||
Official Title ICMJE | A Phase 1, Open-Label, Randomized, Single Dose, 3-Way Crossover Study to Assess the Relative Bioavailability of Solifenacin Liquid Suspension 10 mg (Formulation B) Versus Solifenacin Liquid Suspension 10 mg (Formulation A) and to Assess the Relative Bioavailability of Solifenacin Liquid Suspension 10 mg (Formulation A and B) Versus the VESIcare (Solifenacin Succinate) 10 mg Tablet in Healthy Volunteers | ||||
Brief Summary | A study in healthy volunteers comparing two different liquid formulations of solifenacin with each other and with the tablet formulation. |
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Detailed Description | Subjects will be randomized to one of six treatment sequences. The treatments will be separated by a minimum of 13 days between dosing. Study drug will be administered after an overnight fast, and food will be restricted for an additional four hours after dosing. Except for the water provided with dosing, water will be restricted only during the hour before and the hour after dosing. Subjects will stay at the study site for the first three days of each treatment period. Subjects will return to the study center each morning at the same time of the day for Days 4 through 11 of each study period for the pharmacokinetic blood draw and vital signs. Subjects will be in the study for at least 40 days. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 24 | ||||
Completion Date | July 2011 | ||||
Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01406158 | ||||
Other Study ID Numbers ICMJE | 905-CL-080 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Astellas Pharma Inc | ||||
Study Sponsor ICMJE | Astellas Pharma Inc | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Astellas Pharma Inc | ||||
Verification Date | August 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |