drugset / Trial / NCT01953848

A Study to Evaluate How Tamsulosin (at 1 Dose) and Solifenacin (at 2 Different Doses) Are Taken up From the Intestine, Distributed Through the Body and Eliminated From the Body When Administered in Combination as a Single Tablet (Called EC905)

NCT01953848

Phase 1 Completed 27 enrolled Astellas Pharma Europe B.V.
RandomizedCrossoverOpen-labelBasic science

Summary

Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints related to an enlarged prostate. Solifenacin (sold under the name Vesicare) is used for the treatment of patients suffering from problems related to overactive bladder, such as needing to go to the toilet frequently and often having a sudden urgent need to go to the toilet. Certain patients with an enlarged prostate have complaints that may benefit from a combination of tamsulosin and solifenacin. EC905 is a single tablet containing both tamsulosin and solifenacin. The current study aims at investigating how tamsulosin and solifenacin are taken up from the intestine, distributed through the body and eventually eliminated from the body when taken as a single EC905 tablet.

Timeline

Start
2010-04
Primary completion
2010-07
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Solifenacin Small molecule 6 mg Oral
Subject Solifenacin Small molecule 9 mg Oral
Subject Tamsulosin Other / unclassified 0.4 mg Oral

Indications

No indication recorded.