Healthy Subjects Clinical Trial
Official title:
An Open-label, Single Dose, Randomized, Three-way Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics of Solifenacin and Tamsulosin Administered as Combination Tablet EC905 in Young, Healthy Male Subjects
To evaluate the effect of food (low and high fat breakfast vs. fasting) on the pharmacokinetics (what the body does to the drug) of a single dose of solifenacin and tamsulosin administered as combination tablet EC905. Also to evaluate the safety and tolerability of single doses of EC905 in young, healthy male subjects, when administered under fed (low and high fat) or fasting conditions.
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 after the last 11 day
on-site period, or after withdrawal.
On Day 1 of each of 3 periods, subjects are given a single dose of EC905 under three
conditions (high fat breakfast, low fat breakfast and fasting) in order to evaluate the
effect of food on the PK of solifenacin and tamsulosin HCl. The aim is to show the absence
of a food effect after a low fat breakfast vs. fasting conditions, and to evaluate the food
effect after a high fat breakfast vs. fasting conditions.
Subjects are randomized to one of 6 possible sequences of fasted or fed conditions.
Screening takes place from Day -21 to Day -1. They are admitted to the clinic on Day -1.
Blood sampling for PK assessment is performed from Day 1 to Day 11 of each period. This 11
day on-site period is repeated three times in order to allow all subjects to be dosed under
fed (low and high fat) and fasting conditions.
The 11 day on-site periods are separated by 7-day off site periods; subjects are checked for
eligibility again one day prior to the start of a new dosing day.
Safety assessments are performed throughout the investigational period. Subjects return for
an ESV at least 7 days after the last 11 day on-site 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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