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

NCT01953861 | Completed Phase 1

• 2 other identifiers: 905-CL-0542009-013419-36
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Phase I; Combination tablet EC905; Omnic OCAS®; Vesicare®; Food effect; Vesomni; VesiFlow; Urizia

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic parameter of solifenacin by Area Under the Curve from the time of dosing until the last measurable concentration (AUClast) in plasma

  area under the plasma concentration - time curve (AUC) from the time of dosing until the last measurable concentration (AUClast)

  Days 1-11, 18-28, 35-45

• Pharmacokinetic parameter of solifenacin by maximum concentration (Cmax) in plasma

  maximum concentration (Cmax)

  Days 1-11, 18-28, 35-45

• Pharmacokinetic parameter of tamsulosin HCl by Area Under the Curve from the time of dosing until the last measurable concentration (AUClast) in plasma

  area under the plasma concentration - time curve (AUC) from the time of dosing until the last measurable concentration (AUClast)

  Days 1-11, 18-28, 35-45

• Pharmacokinetic parameter of tamsulosin HCl by maximum concentration (Cmax) in plasma

  maximum concentration (Cmax)

  Days 1-11, 18-28, 35-45

Secondary Outcomes (3)

• Pharmacokinetics profile of solifenacin concentration: (AUCinf), (t1/2), (tmax), (CL/F) and (Vz/F)

  Days 1-11, 18-28, 35-45

• Pharmacokinetics profile of tamsulosin HCl concentration: (AUCinf), (t1/2), (tmax), (CL/F) and (Vz/F)

  Days 1-11, 18-28, 35-45

• Safety and tolerability of single doses of EC905 (solifenacin/tamsulosin HCl) under fed or fasted conditions

  Screening (Day-21 to -1) to ESV (at least 7 days after the last 11 day on-site period, or after withdrawal)

Study Arms (3)

1: fasted

EXPERIMENTAL

EC905 + fasted

Drug: EC905

2: low-fat breakfast

EXPERIMENTAL

EC905 + low-fat breakfast

Drug: EC905

3: high-fat breakfast

EXPERIMENTAL

EC905 + high-fat breakfast

Drug: EC905

Interventions

EC905 DRUG

Oral

Also known as: Vesomni, VesiFlow, Urizia

1: fasted; 2: low-fat breakfast; 3: high-fat breakfast

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (1)

Parexel Early Phase Clinical Unit

Harrow, H1 3UJ, United Kingdom

Location

Study Officials

• Clincial Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

GB (1)