Table 1.
Complete trial schedule for subjects, including preliminary assessment, stage 1, assessment during washout period, stage 2, and post-administration assessment.
| Stage | Preliminary Assessment | Stage 1 | Assessment during Washout Period | Stage 2 | Post-administration Assessment | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Protocol Activities | Day -26~-1 | Day 0 | Day 1 | Day 2 | Day 3 | Days 4~6 | Day 7 | Day 8 | Day 22 | Day 35 | Day 36 | Day 37 | Days 38~40 | Day 41 | Day 42 | Day 49 |
|
| ||||||||||||||||
| Inclusion/Exclusion Decision | ◯ | |||||||||||||||
|
| ||||||||||||||||
| Acquisition of Consent | ◯ | |||||||||||||||
|
| ||||||||||||||||
| Hospitalization | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | |||
|
| ||||||||||||||||
| Administration of Study Drugs | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ||||||||
|
| ||||||||||||||||
| Medical Examination by Physician | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ |
|
| ||||||||||||||||
| Blood Pressure/Pulse Measurement | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | |
|
| ||||||||||||||||
| Body Temperature Measurement | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | |
|
| ||||||||||||||||
| Weight Measurement | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | |||||||||
|
| ||||||||||||||||
| Blood Test | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | |
|
| ||||||||||||||||
| Urinalysis | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | |||
|
| ||||||||||||||||
| Electrocardiogram | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | ◯ | |||