Healthy Subjects Clinical Trial
Official title:
An Open-label, Randomized, Three-period Crossover, Single Dose Study to Compare the Pharmacokinetics of the Final EC905 Formulation to Marketed Solifenacin (Vesicare®) and Tamsulosin OCAS (Omnic OCAS®)
A study to assess the amount of drug in the blood of young to middle aged, healthy, male
subjects after they received the final formulation of EC905 compared to solifenacin
(Vesicare®) and tamsulosin OCAS (Omnic OCAS®).
Subjects are given a single dose of the combination tablet EC905, Vesicare® and Omnic OCAS®
in 3 separate periods.
The subjects are randomized to one of 6 treatment sequence groups.
Subjects are admitted to the clinical unit on Day -1 for pre-dose assessments. They remain
in the clinic for two periods of 11 days and one period of 14 days.
After randomization the subjects receive a single dose treatment on Day 1 followed by blood
sampling for pharmacokinetic (PK) assessment. For both EC905 and Vesicare®, blood sampling
continues for 10 days after dosing; for Omnic OCAS®, it continues for 3 days after dosing.
Each period is separated by a wash-out period of at least 4 day, and subjects are checked
for eligibility again one day prior to the start of a new dosing day.
Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and
concomitant medications are monitored throughout the investigational period.
A blood sample is drawn for CYP2D6 genotyping, in order to evaluate the effect of the CYP2D6
genotype on the PK of tamsulosin.
Subjects return for an End of Study Visit (ESV) 7 days after the last 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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