This is an example of a study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of nicotine. Two different nicotine products were used in the study. Each product was evaluated in a 180-minute test session . There was 1–3 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 were are often used, ; these timepoints presented were used only for illustration to save space.).
The PCLLOQ for the analytes measured were reported, the ; PCULOQs were not reported.
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| Rows 1-3: | Show the Day 1 day 1 pre-dose concentrations of nicotine in plasma 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 day 1 post drug concentrations of nicotine in plasma after the start of delivery of the nicotine. | | Rows 89-16: | Show the Day day 4 pre- and post-dose concentrations of nicotine in plasma. | | Rows 17-18: | Show the Day 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 | PCSTRESU | PCSTAT | PCLLOQ | VISITNUM | VISIT | VISITDY | PCDTC | PCDY | PCTPT | PCTPTNUM | PCTPTREF | PCRFTDTC | PCELTM |
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| 1 | ABC-123A123 | PC | 123-0001A2008 | 1 | Day 1 | A10 | NICOTNE | Nicotine Nicotine | ANALYTE | PLASMA | <0.1 | ng/mL | <0.1 |
| ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T07:15 | 1 | 45 MIN MIN PREDOSE | 1 | Day 1 Dose | 20012021-02-01T08:00 | -PT45M | | 2 | ABC-123A123 | PC | 123-0001A2008 | 2 | Day 1 | A11 | NICOTINE | | ANALYTE | PLASMA | <1.0 | ng/mL | <1.0 |
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| 0.10 | 1 | Day1 | 1 | 2001-02-01T07:30 | 1 | 30 MIN PREDOSE | 2 | Day 1 Dose | 20012021-02-01T08:00 | -PT30M | | 3 | ABC-123A123 | PC | 123-0001A2008 | 3 | Day 1 | A12 | NICOTINE | Nicotine | ANALYTE | PLASMA | <1.0 | ng/mL | <0.1 |
| ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T07:45 | 1 | 15 MIN PREDOSE | 3 | Day 1 Dose | 20012021-02-01T08:00 | -PT15M | | 4 | ABC-123A123 | PC | 123-0001A2008 | 4Day1 | Day 1 | A13 | NICOTINE | Nicotine | ANALYTE | PLASMA | 1.5 | ng/mL | 1.5 | 1.5 | ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T08:02 | 1 | 2 MIN | 4 | Day 1 Dose | 20012021-02-01T08:00 | PT2M | | 5 | ABC-123A123 | PC | 123-0001A2008 | 5 | Day 1 | A14 | NICOTINE | Nicotine | ANALYTE | PLASMA | 3.0 | ng/mL | 3.0 | 3.0 | ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T08:04 | 1 | 4 MIN | 5 | Day 1 Dose | 20012021-02-01T08:00 | PT4M | | 6 | ABC-123A123 | PC | 123-0001A2008 | 6 | Day 1 | A15 | NICOTINE | Nicotine | ANALYTE | PLASMA | 8.0 | ng/mL | 8.0 | 8.0 | ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T08:08 | 1 | 8 MIN | 6 | Day 1 Dose | 20012021-02-01T08:00 | PT8M | | 7 | ABC-123A123 | PC | 123-0001A2008 | 7 | Day 1 | A16 | NICOTINE | Nicotine | ANALYTE | PLASMA | 5.0. | ng/mL | 5.0 | 5.0 | ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T09:00 | 1 | 60 MIN | 7 | Day 1 Dose | 20012021-02-01T08:00 | PT60 | | 8 | ABC-123A123 | PC | 123-0001A2008 | 8 | Day 1 | A16 | NICOTINE | Nicotine | ANALYTE | PLASMA | 3.0 | ng/mL | 3.0 | 3.0 | ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T010:00 | 1 | 120 MIN | 8 | Day 1 Dose | 20012021-02-01T08:00 | PT120 | | 9 | ABC-123A123 | PC | 123-0001A2008 | 9 | Day 4 | A17 | NICOTINE | Nicotine | ANALYTE | PLASMA | 5.44 | ng/mL | 5.44 | 5.44 | ng/mL | 0.10 | 2 | DAY 4 | 4 | 2001-02-04T107:15 | 4 | 45 MIN MIN PREDOSE | 1 | Day 4 Dose | 20012021-02-04T08:00 | -PT45M | | 10 | ABC-123A123 | PC | 123-0001A2008 | 10 | Day 4 | A18 | NICOTINE | Nicotine | ANALYTE | PLASMA | 1.09 | ng/mL | 1.09 | 1.09 | ng/mL | 0.10 | 2 | DAY 4 | 4 | 2001-02-04T07:30 | 4 | 30 MIN PREDOSE | 2 | Day 4 Dose | 20012021-02-04T08:00 | -PT30M | | 11 | ABC-123A123 | PC | 123-0001A2008 | 11 | Day 4 | A19 | NICOTINE | Nicotine | ANALYTE | PLASMA | <0.1 | ng/mL | <0.1 |
| ng/mL | 0.10 | 2 | DAY 4 | 4 | 2001-02-04T07:15 | 4 | 15 MIN REDOSE | 3 | Day 4 Dose | 20012021-02-04T08:00 | -PT15M | | 13 | ABC-123A123 | PC | 123-0001A2008 | 12 | Day 4 | A20 | NICOTINE | Nicotine | ANALYTE | PLASMA | 3.41 | ng/mL | 3.41 | 3.41 | ng/mL | 0.10 | 2 | DAY 4 | 4 | 2001-02-04T08.02 | 4 | 2 MIN | 4 | Day 4 Dose | 20012021-02-04T08:00 | PT2M | | 13 | ABC-123A123 | PC | 123-0001A2008 | 13 | Day 4 | A21 | NICOTINE | Nicotine | ANALYTE | PLASMA | <0.1 | ng/mL | <0.1 |
| ng/mL | 0.10 | 2 | DAY 4 | 4 | 2001-02-04T08:04 | 4 | 4 MIN | 5 | Day 4 Dose | 20012021-02-04T08:00 | PT4M | | 14 | ABC-123A123 | PC | 123-0001A2008 | 14 | Day 4 | A22 | NICOTINE | Nicotine | ANALYTE | PLASMA | 8.74 | ng/mL | 8.74 | 8.74 | ng/mL | 0.10 | 2 | DAY 4 | 4 | 2001-02-04T008.:08 | 4 | 8 MIN | 6 | Day 4 Dose | 20012021-02-04T08:00 | PT8M | | 15 | ABC-123A123 | PC | 123-0001A2008 | 15 | Day 4 | A23 | NICOTINE | Nicotine | ANALYTE | PLASMA | 4.2 | ng/mL | 4.2 | 4.2 | ng/mL | 0.10 | 2 | DAY 4 | 4 | 2001-02-04T09:00 | 4 | 60 MIN | 7 | Day 4 Dose | 20012021-04-11T08:00 | PT160M | | 16 | ABC-123A123 | PC | 123-0001A2008 | 16 | Day 4 | A24 | NICOTINE | Nicotine | ANALYTE | PLASMA | 245 | ng/mL | 245 | 245 | ng/mL | 0.10 | 2 | DAY 4 | 4 | 2001-02-04T010:00 | 4 | 120 MIN | 8 | Day 4 Dose | 20012021-04-11T08:00 | PT120M | | 17 | ABC-123A123 | PC | 123-0001A2008 | 17 | Day 1 | A10 | COTININE | Cotinine Cotinine | ANALYTE | PLASMA | 1 | ng/mL | 1 | 1 | ng/mL | .075 | 1 | DAY 1 | 1 | 2001-02-01T07:15 | 1 | 45 MIN MIN PREDOSE | 1 | Day 1 Dose | 20012021-02-01T08:00 | -PT45M | | 18 | ABC-123A123 | PC | 123-0001A2008 | 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 MIN PREDOSE | 1 | Day 1 Dose | 20012021-02-01T08:00 | -PT45M |
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