Pharmacokinetics - Blood
0.25 hr (immediately post-infusion) sample to be taken only in Treatment Period 1.
text
Blood sample Scheduled Time
time
Blood sample Date Sample Taken
date
Blood sample Actual Time
time
Blood sample Taken
boolean
The samples numbered 1xx are to be taken at Treatment Period 1. The samples numbered 2xx are to be taken at Treatment Period 2. The samples are to be taken consectively at following moments: 101, 201: Predose 102: 0.25 hr (immediately post-infusion) 103, 202: 0.5 hr post-infusion 104, 203: 1 hr 105, 204: 2 hr 106, 205: 3 hr 107, 206: 4 hr 108, 207: 6 hr 109, 208: 10 hr 110, 209: 16 hr 111, 210: 24 hr 112, 211: 36 hr 113, 212: 48 hr 114, 213: 72 hr
integer
Metabolite Profiling - Plasma
A predose blood sample (approximately 20 mL) will be taken from one subject (selected at random.) 0.25 hr (immediately post-infusion) sample to be taken only in Treatment Period 1. 16 hr sample to be taken only in Treatment Period 2.
text
Plasma sample collection Scheduled Time
time
Plasma sample collection Date Sample Taken
date
Plasma sample collection Actual Time
time
Plasma sample collection Taken
boolean
The samples numbered 1xx are to be taken at Treatment Period 1. The samples numbered 2xx are to be taken at Treatment Period 2. The samples are to be taken consectively at following moments: 115, 214: Predose 116: 0.25 hr post-infusion 117, 215: 1 hr 118, 216: 3 hr 119, 217: 6 hr 218: 16 hr
integer
Metabolite Profiling - Urine
Urine sample collection Planned Relative Time Interval
text
Urine sample collection Start Date
date
Urine sample collection Actual Start Time
time
Urine sample collection Stop Date
date
Urine sample collection Actual Stop Time
time
Urine sample collection: Was all of the sample collected for this interval?
text
The samples numbered 1xx are to be taken at Treatment Period 1. The samples numbered 2xx are to be taken at Treatment Period 2. The samples are to be taken consectively at following moments: 120, 219: Predose 121, 220: 0 - 6 hr 122, 221: 6 - 12 hr 123, 222: 12 - 24 hr 124, 223: 24 - 48 hr 125, 224: 48 - 72 hr 126, 225: 72 - 96 hr 127, 226: 96 - 120 hr 128, 227: 120 - 144 hr 129, 228: 144 - 168 hr 130, 229: 168 - 192 hr 131, 230: 192 - 216 hr
integer
Metabolite Profiling - Faeces
Stool sample collection Planned Relative Time Interval
text
Stool sample collection Start Date
date
Stool sample collection Actual Start Time
time
Stool sample collection Stop Date
date
Stool sample collection Actual Stop Time
time
Stool sample collection: Was all of the sample collected for this interval?
text
The samples numbered 1xx are to be taken at Treatment Period 1. The samples numbered 2xx are to be taken at Treatment Period 2. The samples are to be taken consectively at following moments: 132, 231: Predose (if available) 133, 232: 0 - 24 hr 134, 233: 24 - 48 hr 135, 234: 48 - 72 hr 136, 235: 72 - 96 hr 137, 236: 96 - 120 hr 138, 237: 120 - 144 hr 139, 238: 144 - 168 hr 140, 239: 168 - 192 hr 141, 240: 192 - 216 hr 142: 216 - 240 hr 143: 240 - 264 hr 144: 264 - 432 hr
integer