NCT01646294

A Study to Compare the Actions in the Body of Healthy Subjects of Three Modified Release Formulations of YM178 Under Fasted and Fed Conditions With One Immediate Release Formulation of YM178 Under Fasted Conditions

An Exploratory Open Label, Three-way Crossover Study to Compare the Pharmacokinetic Profiles of Three Different YM178 Modified Release (OCAS) Formulations Under Fasted and Fed Conditions With YM178 Immediate Release (IR) Formulation Under Fasted Conditions in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed and eliminated from the body, and how well it is tolerated, when given in three different tablet formulations (sustained release) once a day with and without food, and to compare the results with the profile of the YM178 immediate release formulation taken twice daily without food.

Detailed description

Subjects reside in the clinical research unit for 3 periods of 11 days each, with a washout period of at least 7 days between treatment periods. . Each subject is treated with multiple oral doses of the IR formulation (b.i.d.) under fasted conditions and, OCAS-F, OCAS-M or OCAS-S formulation (q.d.) under fasted and fed conditions (high fat breakfast). The study is completed with a post-study visit between 7 and 14 days after discharge of period 3.

Conditions

• Pharmacokinetics of YM178
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	YM178 modified release (OCAS)	oral
DRUG	YM178 immediate release (IR)	oral

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2012-07-20
• Last updated: 2013-07-02

Locations

1 site across 1 country: Netherlands