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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. ( Note: more More time points may be were used, these timepoints were used only for illustration to save space.).
(Cmax), time to reach Cmax (tmax), and the baseline-corrected area under the plasma concentration–time curves (i) from start of product use (t0) to the last quantifiable nicotine concentration time point (AUC0-last) and (ii) from t0 to 10 minutes after t0 (AUC0-10’). The pharmacokinetic parameters were derived from plasma nicotine concentrations-versus-time data by means of non-compartmental analysis. and corrected for baseline where the baseline (C0) was defined as the average concentration of the three time points prior to t0 (45, 30, and 15 minutes prior to t0). The analysis methods for the baseline corrected values were provided in the study protocol.
The PCLLOQ for the assay used was 0/1 ng/ml , the PCULOQ was 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 in plasma after the start of delivery of the nicotine. | | Rows 8-17 | Show day 1 pre- and post-dose concentrations of nicotine in plasma. | |
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| 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 | A554134-10 | NICO_PAR | NICOTINE PARENT | 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 | A554134-10 | NICO_PAR | | 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 | A554134-10 | NICO_PAR | NICOTINE PARENT | 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 | Day 1 | A554134-11 | NICO_PAR | NICOTINE PARENT | 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 | A554134-11 | NICO_PAR | NICOTINE PARENT | 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 | A554134-11 | NICO_PAR | NICOTINE PARENT | ANALYTE | PLASMA | 8.0 | ng/mL | 8.0 | 8.0 | ng/mL |
| 0.10 |
| 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 | A554134-11 | NICO_PAR | NICOTINE PARENT | 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 | A554134-12 | NICO_PAR | NICOTINE PARENT | 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 | A554134-13 | NICO_PAR | NICOTINE PARENT | 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 | A554134-13 | NICO_PAR | NICOTINE PARENT | 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 | | 12 | ABC-123 | PC | 123-0001 | 11 | Day 4 | A554134-14 | NICO_PAR | NICOTINE PARENT | 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 | A554134-15 | NICO_PART | NICOTINE PARENT | 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 | | 14 | ABC-123 | PC | 123-0001 | 13 | Day 4 | A554134-15 | NICO_PAR | NICOTINE PARENT | 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 | | 15 | ABC-123 | PC | 123-0001 | 14 | Day 4 | A554134-16 | NICO_PAR | NICOTINE PARENT | 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 | | 16 | ABC-123 | PC | 123-0001 | 15 | Day 4 | A554134-16 | NICO_PAR | NICOTINE PARENT | 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 | | 17 | ABC-123 | PC | 123-0001 | 16 | Day 4 | A554134-17 | NICO_PAR | NICOTINE PARENTe | ANALYTE | URINE | 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 | |
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