Healthy Subjects Clinical Trial
Official title:
An Open-label, Randomized, Two-way Crossover, Multiple Dose Study to Evaluate the Steady State Pharmacokinetics of the Two Final Combination Tablet Formulations (EC905; Tamsulosin HCl/ Solifenacin Succinate; 0.4 mg/6 mg and 0.4 mg/9 mg) in Healthy Male Volunteers Over 45 Years of Age
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.
In this study there are two sequence groups with 27 subjects in total. In Period 1, subjects
are randomized to receive one of the two final combination tablet formulations of tamsulosin
HCl and solifenacin succinate. In Period 1, 13 subjects receive one combination and 14
subjects receive the other combination. In Period 2, the alternate treatment is provided.
Screening takes place from Days -21 to -2 before the first admission day (Day -1). EC905 is
administered from Day 1 to Day 12 (treatment period 1), and from Day 13 to Day 24 (treatment
period 2). All treatments are administered with subjects in the fasted state.
Blood samples for pharmacokinetic (PK) analysis of tamsulosin HCl and solifenacin free base
are collected, and assessments of vital signs, safety electrocardiogram (ECG), safety
laboratory, adverse events and concomitant medications are performed.
Subjects are discharged on day 25 and an End of Study Visit takes place at least 10 days
after the second treatment period, or after withdrawal.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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