You are viewing an old version of this page. View the current version .
Compare with Current
View Page History
Version 1
Next »
This is an example of a study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of nicotine pouches. Three different nicotine pouches were used in the study. Each pouch was evaluated in 180 minute test session. AUC and CMAX were to be determined.
pc.xpt
Rows 1-2: Show day 1 pre-dose drug and metabolite concentrations in plasma and urine. Rows 3-4: Show day 1 pre-dose drug and metabolite concentrations in urine. Urine specimens may be collected over an interval; both PCDTC and PCENDTC have been populated with the same value to indicate that these specimens were collected at a point in time rather than over an interval. Rows 5-6: Show specimen properties (VOLUME and PH) for the day 1 pre-dose urine specimens. These have a PCCAT value of "SPECIMEN PROPERTY". Rows 7-12: Show day 1 post-dose drug and metabolite concentrations in plasma. Rows 13-16: Show day 11 drug and metabolite concentrations in plasma. Rows 17-20: Show day 11 drug and metabolite concentrations in urine specimens collected over an interval. The elapsed times for urine samples are calculated as the elapsed time (from the reference time point, PCTPTREF) to the end of the specimen collection interval. Elapsed time values that are the same for urine and plasma samples have been assigned the same value for PCTPT. For the urine samples, the value in PCEVLINT describes the planned evaluation (or collection) interval relative to the time point. The actual evaluation interval can be determined by subtracting PCDTC from PCENDTC. Rows 21-30: Show additional drug and metabolite concentrations and specimen properties related to the day 11 dose.
$titleHtml
pc.xpt
Row STUDYID DOMAIN USUBJID PCSEQ PCGRPID PCREFID PCTESTCD PCTEST PCCAT PCSPEC PCORRES PCORRESU PCSTRESC PCSTRESN PCSTRESU PCSTAT PCLLOQ PCULOQ VISITNUM VISIT VISITDY PCDTC PCENDTC PCDY PCTPT PCTPTNUM PCTPTREF PCRFTDTC PCELTM PCEVLINT 1 ABC-123 PC 123-0001 1 Day 1 A554134-10 DRGA_MET NICOTINE ANALYTE PLASMA <0.1 ng/mL <0.1 ng/mL 0.10 20 1 DAY 1 1 2001-02-01T07:45 1 PREDOSE 0 Day 1 Dose 2001-02-01T08:00 -PT15M 2 ABC-123 PC 123-0001 2 Day 2 A554134-10 DRGA_PAR Drug A Parent ANALYTE PLASMA <0.1 ng/mL <0.1 ng/mL 0.10 20 1 DAY 1 1 2001-02-01T07:45 1 PREDOSE 0 Day 1 Dose 2001-02-01T08:00 -PT15M 3 ABC-123 PC 123-0001 3 Day 3 A554134-11 DRGA_MET Drug A Metabolite ANALYTE URINE <2 ng/mL <2 ng/mL 2.00 500 1 DAY 1 1 2001-02-01T07:45 2001-02-01T07:45 1 PREDOSE 0 Day 1 Dose 2001-02-01T08:00 -PT15M 4 ABC-123 PC 123-0001 4 Day 1 A554134-11 DRGA_PAR Drug A Parent ANALYTE URINE <2 ng/mL <2 ng/mL 2.00 500 1 DAY 1 1 2001-02-01T07:45 2001-02-01T07:45 1 PREDOSE 0 Day 1 Dose 2001-02-01T08:00 -PT15M 5 ABC-123 PC 123-0001 5 Day 1 A554134-11 VOLUME Volume SPECIMEN PROPERTY URINE 3500 mL 100 100 mL 1 DAY 1 1 2001-02-01T07:45 2001-02-01T07:45 1 PREDOSE 0 Day 1 Dose 2001-02-01T08:00 -PT15M 6 ABC-123 PC 123-0001 6 Day 1 A554134-11 PH PH SPECIMEN PROPERTY URINE 5.5 5.5 5.5 1 DAY 1 1 2001-02-01T07:45 2001-02-01T07:45 1 PREDOSE 0 Day 1 Dose 2001-02-01T08:00 -PT15M 7 ABC-123 PC 123-0001 7 Day 1 A554134-12 DRGA_MET Drug A Metabolite ANALYTE PLASMA 5.4 ng/mL 5.4 5.4 ng/mL 0.10 20 1 DAY 1 1 2001-02-01T09:30 1 1H30MIN 1.5 Day 1 Dose 2001-02-01T08:00 PT1H30M 8 ABC-123 PC 123-0001 8 Day 1 A554134-12 DRGA_PAR Drug A Parent ANALYTE PLASMA 4.74 ng/mL 4.74 4.74 ng/mL 0.10 20 1 DAY 1 1 2001-02-01T09:30 1 1H30MIN 1.5 Day 1 Dose 2001-02-01T08:00 PT1H30M 9 ABC-123 PC 123-0001 9 Day 1 A554134-13 DRGA_MET Drug A Metabolite ANALYTE PLASMA 5.44 ng/mL 5.44 5.44 ng/mL 0.10 20 1 DAY 1 1 2001-02-01T14:00 1 6H 6 Day 1 Dose 2001-02-01T08:00 PT6H00M 10 ABC-123 PC 123-0001 10 Day 1 A554134-13 DRGA_PAR Drug A Parent ANALYTE PLASMA 1.09 ng/mL 1.09 1.09 ng/mL 0.10 20 1 DAY 1 1 2001-02-01T14:00 1 6H 6 Day 1 Dose 2001-02-01T08:00 PT6H 11 ABC-123 PC 123-0001 11 Day 1 A554134-14 DRGA_MET Drug A Metabolite ANALYTE PLASMA NOT DONE 20 2 DAY 2 2 2001-02-02T08:00 2 24H 24 Day 1 Dose 2001-02-01T08:00 PT24H 12 ABC-123 PC 123-0001 12 Day 1 A554134-14 DRGA_PAR Drug A Parent ANALYTE PLASMA <0.1 ng/mL <0.1 ng/mL 0.10 20 2 DAY 2 2 2001-02-02T08:00 2 24H 24 Day 1 Dose 2001-02-01T08:00 PT24H 13 ABC-123 PC 123-0001 13 Day 11 A554134-15 DRGA_MET Drug A Metabolite ANALYTE PLASMA 3.41 ng/mL 3.41 3.41 ng/mL 0.10 20 3 DAY 11 11 2001-02-11T07:45 11 PREDOSE 0 Day 11 Dose 2001-02-11T08:00 -PT15M 14 ABC-123 PC 123-0001 14 Day 11 A554134-15 DRGA_PAR Drug A Parent ANALYTE PLASMA <0.1 ng/mL <0.1 ng/mL 0.10 20 3 DAY 11 11 2001-02-11T07:45 11 PREDOSE 0 Day 11 Dose 2001-02-11T08:00 -PT15M 15 ABC-123 PC 123-0001 15 Day 11 A554134-16 DRGA_MET Drug A Metabolite ANALYTE PLASMA 8.74 ng/mL 8.74 8.74 ng/mL 0.10 20 3 DAY 11 11 2001-02-11T09:30 11 1H30MIN 1.5 Day 11 Dose 2001-02-11T08:00 PT1H30M 16 ABC-123 PC 123-0001 16 Day 11 A554134-16 DRGA_PAR Drug A Parent ANALYTE PLASMA 4.2 ng/mL 4.2 4.2 ng/mL 0.10 20 3 DAY 11 11 2001-02-11T09:30 11 1H30MIN 1.5 Day 11 Dose 2001-02-11T08:00 PT1H30M 17 ABC-123 PC 123-0001 17 Day 11 A554134-17 DRGA_MET Drug A Metabolite ANALYTE URINE 245 ng/mL 245 245 ng/mL 2.00 500 3 DAY 11 11 2001-02-11T08:00 2001-02-11T14:03 11 6H 6 Day 11 Dose 2001-02-11T08:00 PT6H -PT6H 18 ABC-123 PC 123-0001 18 Day 11 A554134-17 DRGA_PAR Drug A Parent ANALYTE URINE 13.1 ng/mL 13.1 13.1 ng/mL 2.00 500 3 DAY 11 11 2001-02-11T08:00 2001-02-11T14:03 11 6H 6 Day 11 Dose 2001-02-11T08:00 PT6H -PT6H 19 ABC-123 PC 123-0001 19 Day 11 A554134-17 VOLUME Volume SPECIMEN PROPERTY URINE 574 mL 574 574 mL 3 DAY 11 11 2001-02-11T08:00 2001-02-11T14:03 11 6H 6 Day 11 Dose 2001-02-11T08:00 PT6H -PT6H 20 ABC-123 PC 123-0001 20 Day 11 A554134-17 PH PH SPECIMEN PROPERTY URINE 5.5 5.5 5.5 3 DAY 11 11 2001-02-11T08:00 2001-02-11T14:03 11 6H 6 Day 11 Dose 2001-02-11T08:00 PT6H -PT6H 21 ABC-123 PC 123-0001 21 Day 11 A554134-18 DRGA_MET Drug A Metabolite ANALYTE PLASMA 9.02 ng/mL 9.02 9.02 ng/mL 0.10 20 3 DAY 11 11 2001-02-11T14:00 11 6H 6 Day 11 Dose 2001-02-11T08:00 PT6H 22 ABC-123 PC 123-0001 22 Day 11 A554134-18 DRGA_PAR Drug A Parent ANALYTE PLASMA 1.18 ng/mL 1.18 1.18 ng/mL 0.10 20 3 DAY 11 11 2001-02-11T14:00 11 6H 6 Day 11 Dose 2001-02-11T08:00 PT6H 23 ABC-123 PC 123-0001 23 Day 11 A554134-19 DRGA_MET Drug A Metabolite ANALYTE URINE 293 ng/mL 293 293 ng/mL 2.00 3 DAY 11 11 2001-02-11T14:03 2001-02-11T20:10 11 12H 12 Day 11 Dose 2001-02-11T08:00 PT12H -PT6H 24 ABC-123 PC 123-0001 24 Day 11 A554134-19 DRGA_PAR Drug A Parent ANALYTE URINE 7.1 ng/mL 7.1 7.1 ng/mL 2.00 3 DAY 11 11 2001-02-11T14:03 2001-02-11T20:10 11 12H 12 Day 11 Dose 2001-02-11T08:00 PT12H -PT6H 25 ABC-123 PC 123-0001 25 Day 11 A554134-19 VOLUME Volume SPECIMEN PROPERTY URINE 363 mL 363 363 mL 3 DAY 11 11 2001-02-11T14:03 2001-02-11T20:10 11 12H 12 Day 11 Dose 2001-02-11T08:00 PT12H -PT6H 26 ABC-123 PC 123-0001 26 Day 11 A554134-19 PH PH SPECIMEN PROPERTY URINE 5.5 5.5 5.5 3 DAY 11 11 2001-02-11T14:03 2001-02-11T20:10 11 12H 12 Day 11 Dose 2001-02-11T08:00 PT12H -PT6H 27 ABC-123 PC 123-0001 27 Day 11 A554134-20 DRGA_MET Drug A Metabolite ANALYTE URINE 280 ng/mL 280 280 ng/mL 2.00 4 DAY 12 12 2001-02-11T20:03 2001-02-12T08:10 12 24H 24 Day 11 Dose 2001-02-11T08:00 PT24H -PT12H 28 ABC-123 PC 123-0001 28 Day 11 A554134-20 DRGA_PAR Drug A Parent ANALYTE URINE 2.4 ng/mL 2.4 2.4 ng/mL 2.00 4 DAY 12 12 2001-02-11T20:03 2001-02-12T08:10 12 24H 24 Day 11 Dose 2001-02-11T08:00 PT24H -PT12H 29 ABC-123 PC 123-0001 29 Day 11 A554134-20 VOLUME Volume SPECIMEN PROPERTY URINE 606 mL 606 606 mL 4 DAY 12 12 2001-02-11T20:03 2001-02-12T08:10 12 24H 24 Day 11 Dose 2001-02-11T08:00 PT24H -PT12H 30 ABC-123 PC 123-0001 30 Day 11 A554134-20 PH PH SPECIMEN PROPERTY URINE 5.5 5.5 5.5 4 DAY 12 12 2001-02-11T20:03 2001-02-12T08:10 12 24H 24 Day 11 Dose 2001-02-11T08:00 PT24H -PT12H 31 ABC-123 PC 123-0001 31 Day 11 A554134-21 DRGA_MET Drug A Metabolite ANALYTE PLASMA 3.73 ng/mL 3.73 3.73 ng/mL 0.10 20 4 DAY 12 12 2001-02-12T08:00 12 24H 24 Day 11 Dose 2001-02-11T08:00 PT24H 32 ABC-123 PC 123-0001 32 Day 11 A554134-21 DRGA_PAR Drug A Parent ANALYTE PLASMA <0.1 ng/mL <0.1 ng/mL 0.10 20 4 DAY 12 12 2001-02-12T08:00 12 24H 24 Day 11 Dose 2001-02-11T08:00 PT24H
$warningHtml