Vital Signs - Pre-Dose
e.g. pre-dose
text
Actual Time
time
Systolic Blood Pressure
integer
Diastolic Blood Pressure
integer
Subject position
integer
Heart Rate
integer
Subject's Food Intake
12-Lead ECG - Pre-Dose
Note: Perform ECGs in triplicate at least 2 hours after the subject’s last meal. Note: If abnormal, document abnormality in the Investigator Comment Log. Note: If any clinically significant abnormalities are still noted on pre-dose ECG, the subject is NOT eligible for the study. Check one:
integer
Randomisation Number
Investigational Product
Vital Signs - 2 Hours Post-Dose
e.g., 15 min
text
Actual Time
time
Systolic Blood Pressure
integer
Diastolic Blood Pressure
integer
Subject position
integer
Heart Rate
integer
Vital Signs - 4 Hours Post-Dose
e.g., 15 min
time
Actual Time
time
Systolic Blood Pressure
integer
Diastolic Blood Pressure
integer
Subject position
integer
Heart Rate
integer