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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 180 minute test session..1–3 days in between each product use. Plasma samples were taken at 45, 30, and 15 minutes prior start of product use and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, after start of product use. (More time points were used, these timepoints were used only for illustration to save space.).
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The PCLLOQ for the analytes measured were reported, the PCULOQs were not reported.
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| Rows 1-3: | Show the 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 1 post drug concentrations of nicotine in plasma after the start of delivery of the nicotine. | | Rows 8-16 16: | Show the Day 4 pre- and post-dose concentrations of nicotine in plasma. | | Rows 917-1018: | Show the Day 1 pre-dose plasma concentrations of cotinine and N'-Nitrosonornicotine in plasma. |
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Image Removed | Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCGRPID | PCREFID | PCTESTCD | PCTEST | PCCAT | PCSPEC | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCSTAT | PCLLOQ | PCULOQ | VISITNUM | VISIT | VISITDY | PCDTC | PCDY | PCTPT | PCTPTNUM | PCTPTREF | PCRFTDTC | PCELTM |
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| 1 | ABC-123 | PC | 123-0001 | 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 | 45MIN PREDOSE | 1 | Day 1 Dose | 2001-02-01T08:00 | -PT45M | | 2 | ABC-123 | PC | 123-0001 | 2 | Day 1 | A11 | NICOTINE | | ANALYTE | PLASMA | <1.0 | ng/mL | <1.0 |
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| 1 | Day1 | 1 | 2001-02-01T07:30 | 1 | 30 MIN PREDOSE | 2 | Day 1 Dose | 2001-02-01T08:00 | -PT30M | | 3 | ABC-123 | PC | 123-0001 | 3 | Day 1 | A12 | NICOTINE | Nicotine | ANALYTE | PLASMA | <1.0 | ng/mL | <0.1 |
| ng/mL |
| 0.10 | 20 | 1 | DAY 1 | 1 | 2001-02-01T07:45 | 1 | 15 MIM PREDOSE | 3 | Day 1 Dose | 2001-02-01T08:00 | -PT15M | | 4 | ABC-123 | PC | 123-0001 | 4 | Day1 | A13 | NICOTINE | Nicotine | ANALYTE | PLASMA | 1.5 | ng/mL | 1.5 | 1.5 | ng/mL |
| 0.10 | 500 | 1 | DAY 1 | 1 | 2001-02-01T08:02 | 1 | 2M | 4 | Day 1 Dose | 2001-02-01T08:00 | PT2M | | 5 | ABC-123 | PC | 123-0001 | 5 | Day 1 | A14 | NICOTINE | Nicotine Nicotine | ANALYTE | PLASMA | 3.0 | ng/mL | 3.0 | 3.0 | ng/mL |
| 0.10 | 500 | 1 | DAY 1 | 1 | 2001-02-01T08:04 | 1 | 4M | 5 | Day 1 Dose | 2001-02-01T08:00 | PT4M | | 6 | ABC-123 | PC | 123-0001 | 6 | Day 1 | A15 | NICOTINE | Nicotine | ANALYTE | PLASMA | 8.0 | ng/mL | 8.0 | 8.0 | ng/mL |
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| 1 | DAY 1 | 1 | 2001-02-01T08:08 | 1 | 8M | 6 | Day 1 Dose | 2001-02-01T08:00 | PT8M | | 7 | ABC-123 | PC | 123-0001 | 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 | 60M | 7 | Day 1 Dose | 2001-02-01T08:00 | PT60 | | 8 | ABC-123 | PC | 123-0001 | 8 | Day 1 | A16 | NICOTINE | Nicotine | ANALYTE | PLASMA | 3.0 | ng/mL | 3.0 | 3.0 | ng/mL |
| 0.10 | 20 | 1 | DAY 1 | 1 | 2001-02-01T010:00 | 1 | 120M | 8 | Day 1 Dose | 2001-02-01T08:00 | PT120 | | 9 | ABC-123 | PC | 123-0001 | 9 | Day 4 | A17 | NICOTINE | Nicotine | ANALYTE | PLASMA | 5.44 | ng/mL | 5.44 | 5.44 | ng/mL |
| 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T107:15 | 4 | 45MIN PREDOSE | 1 | Day 4 Dose | 2001-02-04T08:00 | -PT45M | | 10 | ABC-123 | PC | 123-0001 | 10 | Day 4 | A18 | NICOTINE | Nicotine | ANALYTE | PLASMA | 1.09 | ng/mL | 1.09 | 1.09 | ng/mL |
| 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T07:30 | 4 | 30MIN PREDOSE | 2 | Day 4 Dose | 2001-02-04T08:00 | -PT30M | | 11 | ABC-123 | PC | 123-0001 | 11 | Day 4 | A19 | NICOTINE | Nicotine | ANALYTE | PLASMA | <0.1 | ng/mL | <0.1 |
| ng/mL |
| 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T07:15 | 4 | 15 MIN REDOSE | 3 | Day 4 Dose | 2001-02-04T08:00 | -PT15M | | 13 | ABC-123 | PC | 123-0001 | 12 | Day 4 | A20 | NICOTINE | Nicotine | ANALYTE | PLASMA | 3.41 | ng/mL | 3.41 | 3.41 | ng/mL |
| 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T08.02 | 4 | 2M | 4 | Day 4 Dose | 2001-02-04T08:00 | PT2M | | 13 | ABC-123 | PC | 123-0001 | 13 | Day 4 | A21 | NICOTINE | Nicotine | ANALYTE | PLASMA | <0.1 | ng/mL | <0.1 |
| ng/mL |
| 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T08:04 | 4 | 4M | 5 | Day 4 Dose | 2001-02-04T08:00 | PT4M | | 14 | ABC-123 | PC | 123-0001 | 14 | Day 4 | A22 | NICOTINE | Nicotine | ANALYTE | PLASMA | 8.74 | ng/mL | 8.74 | 8.74 | ng/mL |
| 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T008.:08 | 4 | 8M | 6 | Day 4 Dose | 2001-02-04T08:00 | PT8M | | 15 | ABC-123 | PC | 123-0001 | 15 | Day 4 | A23 | NICOTINE | Nicotine | ANALYTE | PLASMA | 4.2 | ng/mL | 4.2 | 4.2 | ng/mL |
| 0.10 | 20 | 2 | DAY 4 | 4 | 2001-02-04T09:00 | 4 | 60M | 7 | Day 4 Dose | 2001-04-11T08:00 | PT160M | | 16 | ABC-123 | PC | 123-0001 | 16 | Day 4 | A24 | NICOTINE | Nicotine | ANALYTE | PLASMA | 245 | ng/mL | 245 | 245 | ng/mL |
| 0.10 | 500 | 2 | DAY 4 | 4 | 2001-02-04T010:00 | 4 | 120M | 8 | Day 4 Dose | 2001-04-11T08:00 | PT120M | | 17 | ABC-123 | PC | 123-0001 | 17 | Day 1 | A10 | COTININE | Cotinine | ANALYTE | PLASMA | <0.1 | ng/mL |
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| 1 | DAY 1 | 1 | 2001-02-01T07:15 | 1 | 45MIN PREDOSE | 1 | Day 1 Dose | 2001-02-01T08:00 | -PT45M | | 18 | ABC-123 | PC | 123-0001 | 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 | 45MIN PREDOSE | 1 | Day 1 Dose | 2001-02-01T08:00 | -PT45M |
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