This is an example of a study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of nicotine pouches. Three Two different nicotine pouches products were used in the study. Each pouch product was evaluated in a 180-minute test session . AUC and CMAX were to be determined. with 1-3 days in between each product use. Plasma samples were taken at 45, 30, and 15 minutes prior to the start of product use and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, and 120 minutes after the start of product use. (More time points are often used; these timepoints presented were used only for illustration to save space.)
The PCLLOQ for the analytes measured were reported; PCULOQs were not reported.
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| Rows 1-23: | Show the day 1 pre-dose drug and metabolite concentrations of nicotine 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. | | at 45, 30 and 15 min before start of delivery of the nicotine. PCDTC is populated to indicate when these specimens were collected. | | Rows 4-8: | Show the day 1 concentrations of nicotine in plasma after the start of delivery of the nicotine. | | Rows 9-16: | Show the day 4 pre- and post-dose concentrations of nicotine in plasma. | | Rows 17-18: | Show the day 1 pre-dose plasma concentrations of cotinine and N'-Nitrosonornicotine in plasma. |
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| Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCGRPID | PCREFID | PCTESTCD | PCTEST | PCCAT | PCSPEC | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESUPCSTAT | PCLLOQ | PCULOQ | VISITNUM | VISIT | VISITDY | PCDTC | PCENDTC | PCDY | PCTPT | PCTPTNUM | PCTPTREF | PCRFTDTC | PCELTM | PCEVLINT |
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| 1 | ABC-123A123 | PC | 123-0001A2008 | 1 | Day 1 | A554134-10 | DRGA_MET | A10 | NICOTNE | NicotineNICOTINE | ANALYTE | PLASMA | <0.1 | ng/mL | <0.1 |
| ng/mL | 0.1020 | 1 | DAY 1 | 1 | 2001-02-01T07:4515 | 1 | 45 MIN PREDOSE | 01 | Day 1 Dose | 20012021-02-01T08:00 | -PT15MPT45M | | 2 | ABC-123A123 | PC | 123-0001A2008 | 2 | Day 21 | A554134-10 | DRGA_PAR | A11 | NICOTINE | Drug A Parent | ANALYTE | PLASMA | <0<1.10 | ng/mL | <0.1 | ng/mL<1.0 |
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| 0.10 | 20 | 1DAY 1 | Day1 | 1 | 2001-02-01T07:4530 | 1 | 30 MIN PREDOSE | 02 | Day 1 Dose | 20012021-02-01T08:00 | -PT15MPT30M | | 3 | ABC-123A123 | PC | 123-0001A2008 | 3 | Day 3 | A554134-11 | DRGA_MET | Day 1 | A12 | NICOTINE | NicotineDrug A Metabolite | ANALYTE | URINEPLASMA<2 | <1.0 | ng/mL | <2<0.1 |
| ng/mL | 20.0010 | 500 | 1 | DAY 1 | 12001-02-01T07:45 | 2001-02-01T07:45 | 1 | 15 MIN PREDOSE | 03 | Day 1 Dose | 20012021-02-01T08:00 | -PT15M | | 4 | ABC-123A123 | PC | 123-0001A2008 | 4 | Day 1 | A554134-11 | DRGA_PAR | A13 | NICOTINE | NicotineDrug A Parent | ANALYTE | URINEPLASMA<2 | 1.5 | ng/mL | 1.5 | 1.5<2 | ng/mL | 20.0050010 | 1 | DAY 1 | 1 | 2001-02-01T0701T08:452001-02-01T07:45 | 1PREDOSE | 2 MIN | 04 | Day 1 Dose | 20012021-02-01T08:00-PT15M | PT2M | | 5 | ABC-123A123 | PC | 123-0001A2008 | 5 | Day 1 | A554134-11A14 | VOLUMENICOTINE | VolumeNicotine | SPECIMEN PROPERTYANALYTE | URINEPLASMA3500 | 3.0 | ng/mL | 100 | 100 | mL | 3.0 | 3.0 | ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T07:452001-02-01T07:4501T08:04 | 1PREDOSE | 4 MIN | 05 | Day 1 Dose | 20012021-02-01T08:00-PT15M | PT4M | | 6 | ABC-123A123 | PC | 123-0001A2008 | 6 | Day 1 | A554134-11 | PH | PH | SPECIMEN PROPERTY | URINE | 5.5 | 5.5 | A15 | NICOTINE | Nicotine | ANALYTE | PLASMA | 8.0 | ng/mL | 8.0 | 8.0 | ng/mL | 0.105.5 | 1 | DAY 1 | 1 | 2001-02-01T0701T08:45 | 2001-02-01T07:45 | 08 | 1PREDOSE | 8 MIN | 06 | Day 1 Dose | 20012021-02-01T08:00-PT15M | PT8M | | 7 | ABC-123A123 | PC | 123-0001A2008 | 7 | Day 1 | A554134-12 | DRGA_MET | A16 | NICOTINE | NicotineDrug A Metabolite | ANALYTE | PLASMA | 5.0.4 | ng/mL | 5.40 | 5.40 | ng/mL | 0.1020 | 1 | DAY 1 | 1 | 2001-02-01T09:3000 | 1 | 1H30MIN | 60 MIN | 71.5 | Day 1 Dose | 20012021-02-01T08:00 | PT1H30MPT60 | | 8 | ABC-123A123 | PC | 123-0001A2008 | 8 | Day 1 | A554134-12 | DRGA_PAR | A16 | NICOTINE | NicotineDrug A Parent | ANALYTE | PLASMA | 43.740 | ng/mL | 43.7404 | 3.740 | ng/mL | 0.10 | 20 | 1 | DAY 1 | 1 | 2001-02-01T0901T010:3000 | 1 | 1H30MIN | 120 MIN | 81.5 | Day 1 Dose | 20012021-02-01T08:00 | PT1H30MPT120 | | 9 | ABC-123A123 | PC | 123-0001A2008 | 9 | Day 14 | A554134-13 | DRGA_MET | A17 | NICOTINE | NicotineDrug A Metabolite | ANALYTE | PLASMA | 5.44 | ng/mL | 5.44 | 5.44 | ng/mL | 0.10 | 202 | 1 | DAY 141 | 4 | 2001-02-01T1404T107:0015 | 146H | 45 MIN PREDOSE | 61 | Day 1 4 Dose | 20012021-02-01T0804T08:00 | PT6H00M-PT45M | | 10 | ABC-123A123 | PC | 123-0001A2008 | 10 | Day 14 | A554134-13 | DRGA_PAR | A18 | NICOTINE | NicotineDrug A Parent | ANALYTE | PLASMA | 1.09 | ng/mL | 1.09 | 1.09 | ng/mL | 0.10 | 20 | 12 | DAY 141 | 4 | 2001-02-01T1404T07:0030 | 146H | 30 MIN PREDOSE | 62 | Day 1 4 Dose | 20012021-02-01T0804T08:00 | PT6H-PT30M | | 11 | ABC-123A123 | PC | 123-0001A2008 | 11 | Day 14 | A554134-14 | DRGA_MET | A19 | NICOTINE | NicotineDrug A Metabolite | ANALYTE | PLASMANOT 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 242 | 4 | 2001-02-02T0804T07:0015 | 2424H | 15 MIN REDOSE | 243 | Day 1 4 Dose | 20012021-02-01T0804T08:00 | PT24H-PT15M | | 13 | ABC-123A123 | PC | 123-0001A2008 | 1312 | Day 114 | A554134-15 | DRGA_MET | A20 | NICOTINE | NicotineDrug A Metabolite | ANALYTE | PLASMA | 3.41 | ng/mL | 3.41 | 3.41 | ng/mL | 0.10 | 20 | 32 | DAY 11411 | 4 | 2001-02-11T07:45 | 11 | PREDOSE | 0 | Day 11 Dose | 04T08.02 | 4 | 2 MIN | 4 | Day 4 Dose | 20212001-02-11T0804T08:00-PT15M | PT2M | | 1413 | ABC-123A123 | PC | 123-0001A2008 | 1413 | Day 114 | A554134-15 | DRGA_PAR | A21 | NICOTINE | NicotineDrug A Parent | ANALYTE | PLASMA | <0.1 | ng/mL | <0.1 |
| ng/mL | 0.10 | 202 | 3 | DAY 11411 | 4 | 2001-02-11T0704T08:4504 | 114 | PREDOSE4 MIN | 05 | Day 11 4 Dose | 20012021-02-11T0804T08:00-PT15M | PT4M | | 1514 | ABC-123A123 | PC | 123-0001A2008 | 1514 | Day 114 | A554134-16 | DRGA_MET | A22 | NICOTINE | NicotineDrug A Metabolite | ANALYTE | PLASMA | 8.74 | ng/mL | 8.74 | 8.74 | ng/mL | 0.10 | 202 | 3 | DAY 11411 | 4 | 2001-02-11T0904T008.:3008 | 114 | 1H30MIN | 8 MIN | 61.5 | Day 11 4 Dose | 20012021-02-11T0804T08:00 | PT1H30MPT8M | | 1615 | ABC-123A123 | PC | 123-0001A2008 | 1615 | Day 114 | A554134-16 | DRGA_PAR | A23 | NICOTINE | NicotineDrug A Parent | ANALYTE | PLASMA | 4.2 | ng/mL | 4.2 | 4.2 | ng/mL | 0.10 | 20 | 32 | DAY 11411 | 4 | 2001-02-11T0904T09:3000 | 114 | 1H30MIN | 60 MIN | 71.5 | Day 11 4 Dose | 20012021-0204-11T08:00 | PT1H30MPT160M | | 1716 | ABC-123A123 | PC | 123-0001A2008 | 1716 | Day 114 | A554134-17 | DRGA_MET | A24 | NICOTINE | NicotineDrug A Metabolite | ANALYTE | URINEPLASMA | 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 | 0.10 | 2 | DAY 4 | 411 | 2001-02-11T0804T010:00 | 2001-02-11T14:03 | 11 | 6H | 6 | Day 11 Dose | 4 | 120 MIN | 8 | Day 4 Dose | 2021-042001-02-11T08:00 | 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 | PT120M | | 17 | A123 | PC | A2008 | 17 | Day 1 | A10 | COTININE | Cotinine | ANALYTE | PLASMA | 1 | 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 | 0.10075 | 20 | 31 | DAY 11111 | 1 | 2001-02-11T14:00 | 11 | 6H | 6 | Day 11 Dose | 01T07:15 | 1 | 45 MIN PREDOSE | 1 | Day 1 Dose | 2021-02-01T08:00 | -PT45M | | 18 | A123 | PC | A2008 | 18 | Day 1 | A10 | NNN | N'-Nitrosonornicotine | ANALYTE | PLASMA | <0.1 | pg/mL | <.3 |
| pg/mL | 0.3 | 1 | DAY 1 | 1 | 2001-02-01T07:15 | 1 | 45 MIN PREDOSE | 1 | Day 1 Dose | 2021-02-01T08:00 | -PT45M | 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 |
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