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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
27
Oral
Parexel Early Phase Clinical Unit
Harrow, United Kingdom
Pharmacokinetic profile of tamsulosin HCl by Area Under the Curve during the time interval between consecutive dosing
Area under the plasma concentration - time curve during the time interval between consecutive dosing (AUCtau)
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Pharmacokinetic profile of tamsulosin HCl by Maximum concentration
Maximum concentration ( Cmax)
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Pharmacokinetic profile of solifenacin succinate by Area Under the Curve during the time interval between consecutive dosing
Area under the plasma concentration - time curve during the time interval between consecutive dosing (AUCtau)
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Pharmacokinetic profile of solifenacin succinate by Cmax (Maximum concentration)
Maximum concentration ( Cmax)
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Pharmacokinetics profile of tamsulosin HCl concentration: Observed trough concentration, Peak Trough Ratio, time to attain Cmax,and apparent total body clearance
Observed trough concentration (Ctrough), Peak Trough Ratio (PTR), time to attain Cmax (tmax), apparent total body clearance (CL/F)
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Pharmacokinetics profile of solifenacin succinate concentration: Observed trough concentration, Peak Trough Ratio, time to attain Cmax,and apparent total body clearance
Observed trough concentration (Ctrough), Peak Trough Ratio (PTR), time to attain Cmax (tmax), apparent total body clearance (CL/F)
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Safety and tolerability of EC905
Adverse events, ECG, vital signs, safety laboratory assessments, physical examination
Time frame: Day -21 to End of Study Visit
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