Clinical Trial Schedule
Visit | Visit 1 (screening) (–21~0 day) |
Visit 2 (0 day) |
Visit 3 (42±7 day) |
Visit 4 (84±7 day) |
---|---|---|---|---|
Informed consent | ○ | |||
Incousion/exclusion criteria | ○ | ○ | ||
Demographic information | ○ | |||
Past history investigation | ○ | |||
Physical examination | ○ | ○ | ○ | ○ |
Vital signs | ○ | ○ | ○ | ○ |
Clinical laboratory examination | ○ | ○ | ○ | |
Experimental/control capsule provision | ○ | ○ | ||
Outcome measures | ○ | ○ | ○ | |
Questionnaires | ○ | ○ | ||
Adverse events | ○ | ○ | ||
Co-administraion drug investigation | ○ | ○ | ○ | |
Medication compliance assessment | ○ | ○ |