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

NCT01953861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2014-05-29

No results posted yet for this study

Summary

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.

Conditions

  • EC905
  • Pharmacokinetics
  • Healthy Subjects

Interventions

DRUG

EC905

Oral

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Clincial Study Manager · Astellas Pharma Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01953861 on ClinicalTrials.gov