Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-04 @ 8:50 AM
Study NCT ID:
NCT01953861
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2013-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Whether Food Has an Effect on the Uptake of Solifenacin and Tamsulosin When Administered in a Combination Tablet
Sponsor:
Astellas Pharma Europe B.V.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-013419-36 | EUDRACT_NUMBER | None | View |