Pharmacokinetics of MCS in Healthy Volunteers

Phase 1

• Conditions: Healthy
• Interventions: Drug: MCS-2 soft-gel capsule

• Registration Number: NCT01003171
• Lead Sponsor: Health Ever Bio-Tech Co., Ltd.

Brief Summary

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

Detailed 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 Timeline

• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-28
• Last Update Posted: 2011-06-30
• Study Start: 2011-08
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Normal healthy volunteers
• 18 years of age or older

Exclusion Criteria

• Subjects who can not comply with the study procedures or sign the informed consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MCS-2	MCS-2 soft-gel capsule	-

Primary Outcome Measures

Name	Time	Method
Serum MCS and other components levels	21 days

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	21 days