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Pharmacokinetics of MCS in Healthy Volunteers

NCT ID: NCT01003171

Last Updated: 2011-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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Pharmacokinetics PK MCS Benign Prostatic Hyperplasia Multi-Carotenoids Healthy subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MCS-2

Group Type EXPERIMENTAL

MCS-2 soft-gel capsule

Intervention Type DRUG

MCS-2 30 mg/day

Interventions

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MCS-2 soft-gel capsule

MCS-2 30 mg/day

Intervention Type DRUG

Other Intervention Names

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MUS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Ever Bio-Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Health Ever Bio-Tech Co., Ltd.

Central Contacts

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Fu-Feng Kuo

Role: CONTACT

Phone: +886-2-25788621

Email: [email protected]

Other Identifiers

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MCS-2-US-pk

Identifier Type: -

Identifier Source: org_study_id