A Study to Evaluate Whether Food Has an Effect on the Uptake of Solifenacin and Tamsulosin When Administered in a Combination Tablet
Launched by ASTELLAS PHARMA EUROPE B.V. · Sep 26, 2013
Trial Information
Current as of May 23, 2025
Completed
Keywords
ClinConnect Summary
Subjects are admitted to the clinic on Day -1 and receive a single dose of the combination tablet EC905 on the first day of 3 periods, under three conditions (high fat breakfast, low fat breakfast, and fasting) in order to evaluate the effect of food.
Blood sampling for pharmacokinetic (PK) assessment is performed on the dosing day and for 11 days after dosing in each period. This 11-day on-site period is repeated three times so that all subjects are dosed under all conditions. Each period is separated by 7 days off site.
Subjects return for an End of Study Visit (ESV) at least 7 days aft...
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • BMI between 18.5 and 30.0 kg/m2, inclusive.
- Exclusion Criteria:
- • Known or suspected hypersensitivity to solifenacin, tamsulosin or any of the other recipients of EC905.
- • Any of the contraindications or precautions for use as mentioned in the applicable sections of the Summary of Product Characteristics (SPC) of tamsulosin or solifenacin
- • Use of grapefruit (more than 3 x 200 ml) or marmalade (more than three times) in the week prior to admission to the Clinical Unit, as reported by the subject.
About Astellas Pharma Europe B.V.
Astellas Pharma Europe B.V. is a European affiliate of Astellas Pharma Inc., a global pharmaceutical company dedicated to improving the health of patients worldwide through innovative medicines. With a strong focus on urology, oncology, immunology, and neuroscience, Astellas is committed to advancing therapeutic solutions that address unmet medical needs. The organization emphasizes research and development, leveraging cutting-edge science and technology to enhance patient care. Astellas Pharma Europe B.V. adheres to the highest ethical standards in its clinical trials, ensuring safety, efficacy, and regulatory compliance while fostering collaboration with healthcare professionals and stakeholders across the region.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Harrow, , United Kingdom
Patients applied
Trial Officials
Clincial Study Manager
Study Chair
Astellas Pharma Europe B.V.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials