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(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 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 analytes measured were reported, the PCULOQs were not reported
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| Rowcaps |
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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 1 Day 1 post drug concentrations of nicotine in plasma after the start of delivery of the nicotine. | | Rows 8-17 16 | Show day 1 the Day 4 pre- and post-dose concentrations of nicotine in plasma. | | Rows 9-10 | Show the Day 1 pre-dose plasma concentrations of cotinine and N'-Nitrosonornicotine in plasma. |
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| Dataset2 |
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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 | 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 | 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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| 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 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 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 | NICOTINENICOTINE | Nicotine | 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 | A16 | NICOTINENICOTINE | 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 | NICOTINENICOTINE | 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 | NICOTINENICOTINE | 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 | NICOTINENICOTINE | 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 | | 1211 | ABC-123 | PC | 123-0001 | 11 | Day 4 | A19 | NICOTINENICOTINE | 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 | NICOTINENICOTINE | 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 | | 1413 | ABC-123 | PC | 123-0001 | 13 | Day 4 | A21 | NICOTINENICOTINE | 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 | | 1514 | ABC-123 | PC | 123-0001 | 14 | Day 4 | A22 | NICOTINENICOTINE | 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 | | 1615 | ABC-123 | PC | 123-0001 | 15 | Day 4 | A23 | NICOTINENICOTINE | 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 | | 1716 | ABC-123 | PC | 123-0001 | 16 | Day 4 | A24 | NICOTINENICOTINE | 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 | | 1817 | ABC-123 | PC | 123-0001 | 17 | Day 1 | A10 | COTININECOTININE | 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 | | 1918 | 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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