Healthy Subjects Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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