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A Study to Evaluate Whether Verapamil Has an Effect on the Uptake and Elimination of Solifenacin and Tamsulosin When Administered in a Combination Tablet

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug-Drug Interaction (DDI); Healthy Subjects

Intervention: EC905 (Drug); verapamil (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Astellas Pharma Europe B.V.

Official(s) and/or principal investigator(s):
Clinical Study Manager, Study Chair, Affiliation: Astellas Pharma Europe B.V.

Summary

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.

Clinical Details

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.

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Pharmacokinetics of tamsulosin OCAS in plasma: AUCtau

Pharmacokinetics of solifenacin in plasma: AUCtau

Pharmacokinetics of tamsulosin OCAS in plasma: Cmax

Pharmacokinetics of solifenacin in plasma: Cmax

Secondary outcome:

Pharmacokinetics of combined doses of tamsulosin OCAS and solifenacin in steady state, and verapamil

Safety and tolerability of the interaction between combined doses of tamsulosin OCAS and solifenacin, and verapamil

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Body Mass Index between 18. 5 and 30. 0 kg/m2, inclusive

Exclusion Criteria:

- Known or suspected hypersensitivity to EC905 or any of the components of the

formulation used

- Known or suspected hypersensitivity to verapamil or any of the components of the

formulation used

- Regular use of any inducer of liver metabolism (e. g. barbiturates, rifampin) in the 3

months prior to admission to the Clinical Unit

Locations and Contacts

SGS Aster, Paris 75015, France
Additional Information

Link to Results on JAPIC

Starting date: August 2009
Last updated: May 29, 2014

Page last updated: August 23, 2015

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