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NCT01003171 Clinical Trial

Pharmacokinetics of MCS in Healthy Volunteers

Healthy Clinical Trial

— MCS-2-US-pk  

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 Details — Status: Not yet recruiting

Administrative data
NCT number NCT01003171
Other study ID # MCS-2-US-pk
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received October 26, 2009
Last updated June 28, 2011
Start date August 2011
Est. completion date December 2012

Study information
Verified date June 2011
Source Health Ever Bio-Tech Co., Ltd.
Contact Fu-Feng Kuo
Phone +886-2-25788621
Email Healthe@ms76.hinet.net
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 12
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• MCS-2 soft-gel capsule
MCS-2 30 mg/day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Health Ever Bio-Tech Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Serum MCS and other components levels 21 days No
Secondary Incidence of treatment-emergent adverse events 21 days Yes
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