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Pharmacokinetics of MCS in Healthy Volunteers — MCS-2-US-pk  

Healthy Clinical Trial

Official title:
An Open-Label, Multiple-Dose Study of MCS-2 to Examine the Pharmacokinetics of MCS and Other Components After Once-daily Oral Dosing in Healthy Adult Volunteers

Clinical Trial Summary

This study is to examine the pharmacokinetics, absorption and serum concentrations of MCS and other components after once-daily oral dosing of MCS.

Clinical Trial Description

This study is an open-label, multiple-dose study, whose objective is to examine the pharmacokinetics of MCS and other components after once-daily oral dosing for 21 days.

Subjects will undergo a 14-day washout phase and then enter the 21-day treatment phase. During the treatment phase, subjects will receive MCS, once-daily within one hour after the evening meal. After completion of the treatment phase, subjects will enter a post-treatment 42-day washout phase. Throughout each of these phases, blood samples will be collected and assayed for concentrations of MCS and other components. The duration of protocol participation is expected to be 77 days for each eligible subject who completes the study. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01003171
Study type Interventional
Source Health Ever Bio-Tech Co., Ltd.
Contact Fu-Feng Kuo
Phone +886-2-25788621
Email Healthe@ms76.hinet.net
Status Not yet recruiting
Phase Phase 1
Start date August 2011
Completion date December 2012
View Details
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