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 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).
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: | 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 | PCSTRESU | PCSTAT | PCLLOQ | 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 45 MIN 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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| 0.10 | 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 | 1 | DAY 1 | 1 | 2001-02-01T07:45 | 1 | 15 MIM MIN 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 | 1 | DAY 1 | 1 | 2001-02-01T08:02 | 12M | 2 MIN | 4 | Day 1 Dose | 2001-02-01T08:00 | PT2M | 5 | ABC-123 | PC | 123-0001 | 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 | 14M | 4 MIN | 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 |
| 0.10 | 1 | DAY 1 | 1 | 2001-02-01T08:08 | 18M | 8 MIN | 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 | 160M | 60 MIN | 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 | 1 | DAY 1 | 1 | 2001-02-01T010:00 | 1120M | 120 MIN | 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 | 2 | DAY 4 | 4 | 2001-02-04T107:15 | 4 | 45MIN 45 MIN 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 | 2 | DAY 4 | 4 | 2001-02-04T07:30 | 4 | 30MIN 30 MIN 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 | 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 | 2 | DAY 4 | 4 | 2001-02-04T08.02 | 42M | 2 MIN | 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 | 2 | DAY 4 | 4 | 2001-02-04T08:04 | 44M | 4 MIN | 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 | 2 | DAY 4 | 4 | 2001-02-04T008.:08 | 48M | 8 MIN | 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 | 2 | DAY 4 | 4 | 2001-02-04T09:00 | 460M | 60 MIN | 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 | 2 | DAY 4 | 4 | 2001-02-04T010:00 | 4120M | 120 MIN | 8 | Day 4 Dose | 2001-04-11T08:00 | PT120M | 17 | ABC-123 | PC | 123-0001 | 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 | 45MIN 45 MIN 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 45 MIN PREDOSE | 1 | Day 1 Dose | 2001-02-01T08:00 | -PT45M |
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