Healthy Subjects Clinical Trial
Official title:
A Phase 1, Open-label, One-sequence Study to Assess the Effect of Verapamil on the Steady State Pharmacokinetics of Solifenacin and Tamsulosin Administered as a Combination Tablet EC905 in Healthy Male Subjects.
This study investigates the effect of the co-administration of verapamil on the steady-state pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet, EC905.
The effect of the co-administration of verapamil on the steady state PK of solifenacin
succinate and tamsulosin HCl OCAS (Oral Controlled Absorption System) is evaluated in this
study.
Verapamil has been chosen to represent the effect of moderate CYP3A4 inhibitors on the
combined administration of solifenacin and tamsulosin given as combination tablet EC905.
Subjects are admitted to the clinic on Day -1. From Days 1-10, they receive one daily dose
of EC905 to obtain steady state, followed by 20 days (Days 11-30) combined dosing of EC905
and verapamil.
On Day 10 a 24-hour PK profile is obtained for solifenacin/tamsulosin. After the last dosing
on Day 30, a post-dose 24-hour PK profile for solifenacin/tamsulosin and verapamil is
obtained.
Additionally, vital signs, safety ECG (Electrocardiogram) measurements, safety laboratory
assessments, adverse events and concomitant medications are monitored throughout the
investigational period.
Subjects return for an ESV (End of Study Visit) 10 days after the last dosing.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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