A study to compare the pharmacokinetics of tamsulosin HCl and solifenacin succinate after co-administration of single entity tablets and of the combination tablet EC905 under steady state conditions at three dose strengths.
There will be 3 dose cohorts of 15 subjects each. In Period 1, subjects will be randomized to either receive multiple doses of both tamsulosin HCl and solifenacin succinate as single entity tablets, or the combination tablet EC905. The alternate treatment will be provided in Period 2. The cohorts will be balanced for period effects and first-order carry over effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
46
Site NL1
Zuidlaren, Drenthe, Netherlands
Pharmacokinetics (PK) of tamsulosin HCl and solifenacin succinate in plasma: AUCtau
AUCtau: area under the concentration - time curve (AUC) during the time interval between consecutive dosing
Time frame: Day 12
PK of tamsulosin HCl and solifenacin succinate in plasma: Cmax
Cmax: maximum concentration
Time frame: Day 12
Safety profile assessed by adverse events, physical examination and vital signs, routine safety laboratory tests, and 12-lead ECG
Vital signs include blood pressure, pulse rate. Safety laboratory test includes urinalysis, hematology, and biochemistry. ECG: Electrocardiogram
Time frame: Day 0 up to and including the post study visit (the PSV is scheduled between 7 to 14 days after (early) discharge on study day 13)
PK profile Ctrough
Ctrough: Trough concentration
Time frame: Day 10, 11, 12, 13
PK profile PTR
PTR: Peak Trough Ratio
Time frame: Day 12
PK profile Tmax
Tmax: Time to attain Cmax
Time frame: Day 12
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