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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

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

Condition(s) targeted: EC905; Pharmacokinetics; Healthy Subjects

Intervention: EC905 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Astellas Pharma Europe B.V.

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

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.

Clinical Details

Official title: An Open-label, Single Dose, Randomized, Three-way Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics of Solifenacin and Tamsulosin Administered as Combination Tablet EC905 in Young, Healthy Male Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

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

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

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

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

Secondary outcome:

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

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

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

Detailed description:

Subjects are admitted to the clinic on Day - 1 and receive a single dose of the combination

tablet EC905 on the first day of 3 periods, under three conditions (high fat breakfast, low fat breakfast, and fasting) in order to evaluate the effect of food. Blood sampling for pharmacokinetic (PK) assessment is performed on the dosing day and for 11 days after dosing in each period. This 11-day on-site period is repeated three times so that all subjects are dosed under all conditions. Each period is separated by 7 days off site. Subjects return for an End of Study Visit (ESV) at least 7 days after the last 11 day on-site period, or after withdrawal. On Day 1 of each of 3 periods, subjects are given a single dose of EC905 under three conditions (high fat breakfast, low fat breakfast and fasting) in order to evaluate the effect of food on the PK of solifenacin and tamsulosin HCl. The aim is to show the absence of a food effect after a low fat breakfast vs. fasting conditions, and to evaluate the food effect after a high fat breakfast vs. fasting conditions. Subjects are randomized to one of 6 possible sequences of fasted or fed conditions.

Screening takes place from Day - 21 to Day -1. They are admitted to the clinic on Day -1.

Blood sampling for PK assessment is performed from Day 1 to Day 11 of each period. This 11 day on-site period is repeated three times in order to allow all subjects to be dosed under fed (low and high fat) and fasting conditions. The 11 day on-site periods are separated by 7-day off site periods; subjects are checked for eligibility again one day prior to the start of a new dosing day. Safety assessments are performed throughout the investigational period. Subjects return for an ESV at least 7 days after the last 11 day on-site period, or after withdrawal.

Eligibility

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

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.

Locations and Contacts

Parexel Early Phase Clinical Unit, Harrow H1 3UJ, United Kingdom
Additional Information

Link to Results on JAPIC

Starting date: April 2010
Last updated: May 28, 2014

Page last updated: August 23, 2015

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