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A Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Adult Volunteers

2014-08-27 04:00:29 | BioPortfolio

Summary

The purpose of this study is to assess the pharmacokinetic interaction of multiple-dose ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone and in combination with ketoconazole in healthy adult volunteers.

Description

A single oral dose of YM178 OCAS will be administered on 2 separate occasions: alone on Day 1 of Period 1 and during multiple- dosing of ketoconazole on Day 4 of Period 2. In Period 2, an oral dose of ketoconazole will be administered once daily on Days 1-9.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy Subjects

Intervention

YM178 OCAS, Ketoconazole

Location

MDS Pharma Services (US) Inc.
Lincoln
Nebraska
United States
68502

Status

Completed

Source

Astellas Pharma Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:29-0400

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