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 with 1–3 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, the ; PCULOQs were not reported.
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| Rows 1-3: | Show the Day 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 | PCSTRESUPCSTAT | PCLLOQ | VISITNUM | VISIT | VISITDY | PCDTC | PCDY | PCTPT | PCTPTNUM | PCTPTREF | PCRFTDTC | PCELTM |
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| 1 | APP-123A123 | PC | 123-0001A2008 | 1 | Day 1 | A10 | NICOTNE | Nicotine | ANALYTE | PLASMA | <0.1 | ng/mL | <0.1 |
| ng/mL | 0.10 | 1 | DAY 1 | 1 | 2001-02-01T07:15 | 1 | 45 MIN PREDOSE | 1 | Day 1 Dose | 20012021-02-01T08:00 | -PT45M | | 2 | APP-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 | APP-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 | APP-123A123 | PC | 123-0001A2008 | 4 | 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 | APP-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 | APP-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 | APP-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 | APP-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 | APP-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 PREDOSE | 1 | Day 4 Dose | 20012021-02-04T08:00 | -PT45M | | 10 | APP-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 | APP-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 | APP-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 | APP-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 | APP-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 | APP-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 | APP-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 | APP-123A123 | PC | 123-0001A2008 | 17 | Day 1 | A10 | COTININE | Cotinine | ANALYTE | PLASMA | 1 | ng/mL | 1 | 1 | ng/mL | .075 | 1 | DAY 1 | 1 | 2001-02-01T07:15 | 1 | 45 MIN PREDOSE | 1 | Day 1 Dose | 20012021-02-01T08:00 | -PT45M | | 18 | APP-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 PREDOSE | 1 | Day 1 Dose | 20012021-02-01T08:00 | -PT45M |
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