Pharmacokinetic blood sampling
Row number
integer
Date of Blood Sampling
date
Day 1: each one measurement at Pre-dose, 15mins, 30mins, 40mins, 1hr, 2hrs, 3hrs, 4hrs, 8hrs, 12hrs, 24hrs. Day 3, 5, 8, 10: each one measurement at Pre-dose, 24hrs. Day 7, 12: one measurement at Pre-Dose. Day 13: each one measurement at Pre-dose, 15mins, 30mins, 40mins, 1hr, 2hrs, 3hrs, 4hrs, 8hrs, 12hrs. Day 14: one measurement at 24hrs. 8hrs: 15mcg and 25mcg dose groups only. 12hrs: 25mcg dose group only. 24hrs: To be performed immediately prior to dosing on the following day.
text
Actual time of Blood Sampling
time
Sample number of Blood Sampling
text
In this study, this item should not be filled in at day 1.
boolean
Pharmacokinetic urine sampling
Row number
integer
Planned relative time interval of urine sampling
text
Start date of urine sampling
date
Actual start time of urine sampling
time
Stop date of urine sampling
date
Actual stop time of urine sampling
time
Sample number of urine sampling
text
Total urine sample volume
integer
10ml aliquot of urine sampling taken
boolean
If NO, record details on the INVESTIGATOR COMMENT LOG.
boolean