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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Treatments: Solifenacin Succinate; Tamsulosin

Criteria

Inclusion Criteria:

• BMI between 18.5 and 30.0 kg/m2, inclusive.

Exclusion Criteria:

• Known or suspected hypersensitivity to solifenacin, tamsulosin or any of the other recipients of EC905.

• Any of the contraindications or precautions for use as mentioned in the applicable sections of the Summary of Product Characteristics (SPC) of tamsulosin or solifenacin

• Use of grapefruit (more than 3 x 200 ml) or marmalade (more than three times) in the week prior to admission to the Clinical Unit, as reported by the subject.