Pharmacokinetics of MCS in Healthy Volunteers (MCS-2-US-pk)

Health Ever Bio-Tech

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: MCS-2 soft-gel capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01003171

MCS-2-US-pk

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

MCS-2

Experimental group

Treatment:

Drug: MCS-2 soft-gel capsule