Healthy
Conditions
Keywords
Pharmacokinetics, PK, MCS, Benign Prostatic Hyperplasia, Multi-Carotenoids, Healthy subjects
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.
Interventions
DRUGMCS-2 soft-gel capsule
MCS-2 30 mg/day
Sponsors
Health Ever Bio-Tech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum MCS and other components levels | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events | 21 days |
Contacts
Primary ContactFu-Feng Kuo
Outcome results
None listed