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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 a 180 minute test session with 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.  

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.

pc.xpt

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RowSTUDYIDDOMAINUSUBJIDPCSEQPCGRPIDPCREFIDPCTESTCDPCTESTPCCATPCSPECPCORRESPCORRESUPCSTRESCPCSTRESNPCSTRESUPCLLOQVISITNUMVISITVISITDYPCDTCPCDYPCTPTPCTPTNUMPCTPTREFPCRFTDTCPCELTM
1A123PCA20081Day 1A10NICOTNENicotineANALYTEPLASMA<0.1ng/mL<0.1
ng/mL0.101DAY 112001-02-01T07:15145 MIN PREDOSE1Day 1 Dose2021-02-01T08:00-PT45M
2A123PCA20082Day 1A11NICOTINE

Nicotine

ANALYTEPLASMA<1.0ng/mL<1.0

0.101Day112001-02-01T07:30130 MIN PREDOSE2Day 1 Dose2021-02-01T08:00-PT30M
3A123PCA20083Day 1A12NICOTINENicotineANALYTEPLASMA<1.0ng/mL<0.1
ng/mL0.101DAY 112001-02-01T07:45115 MIN PREDOSE3Day 1 Dose2021-02-01T08:00-PT15M
4A123PCA20084Day 1A13NICOTINENicotineANALYTEPLASMA1.5ng/mL1.51.5ng/mL0.101DAY 112001-02-01T08:0212 MIN4Day 1 Dose2021-02-01T08:00PT2M
5A123PCA20085Day 1A14NICOTINENicotineANALYTEPLASMA3.0ng/mL3.03.0ng/mL0.101DAY 112001-02-01T08:0414 MIN5Day 1 Dose2021-02-01T08:00PT4M
6A123PCA20086Day 1A15NICOTINENicotineANALYTEPLASMA8.0ng/mL8.08.0ng/mL0.101DAY 112001-02-01T08:0818 MIN6Day 1 Dose2021-02-01T08:00PT8M
7A123PCA20087Day 1A16NICOTINENicotineANALYTEPLASMA5.0.ng/mL5.05.0ng/mL0.101DAY 112001-02-01T09:00160 MIN7Day 1 Dose2021-02-01T08:00PT60
8A123PCA20088Day 1A16NICOTINENicotineANALYTEPLASMA3.0ng/mL3.03.0ng/mL0.101DAY 112001-02-01T010:001120 MIN8Day 1 Dose2021-02-01T08:00PT120
9A123PCA20089Day 4A17NICOTINENicotineANALYTEPLASMA5.44ng/mL5.445.44ng/mL0.102DAY 442001-02-04T107:15445 MIN PREDOSE1Day 4 Dose2021-02-04T08:00-PT45M
10A123PCA200810Day 4A18NICOTINENicotineANALYTEPLASMA1.09ng/mL1.091.09ng/mL0.102DAY 442001-02-04T07:30430 MIN PREDOSE2Day 4 Dose2021-02-04T08:00-PT30M
11A123PCA200811Day 4A19NICOTINENicotineANALYTEPLASMA<0.1ng/mL<0.1
ng/mL0.102DAY 442001-02-04T07:15415 MIN REDOSE3Day 4 Dose2021-02-04T08:00-PT15M
13A123PCA200812Day 4A20NICOTINENicotineANALYTEPLASMA3.41ng/mL3.413.41ng/mL0.102DAY 442001-02-04T08.0242 MIN4Day 4 Dose2021-02-04T08:00PT2M
13A123PCA200813Day 4A21NICOTINENicotineANALYTEPLASMA<0.1ng/mL<0.1
ng/mL0.102DAY 442001-02-04T08:0444 MIN5Day 4 Dose2021-02-04T08:00PT4M
14A123PCA200814Day 4A22NICOTINENicotineANALYTEPLASMA8.74ng/mL8.748.74ng/mL0.102DAY 442001-02-04T008.:0848 MIN6Day 4 Dose2021-02-04T08:00PT8M
15A123PCA200815Day 4A23NICOTINENicotineANALYTEPLASMA4.2ng/mL4.24.2ng/mL0.102DAY 442001-02-04T09:00460 MIN7Day 4 Dose2021-04-11T08:00PT160M
16A123PCA200816Day 4A24NICOTINENicotineANALYTEPLASMA245ng/mL245245ng/mL0.102DAY 442001-02-04T010:004120 MIN8Day 4 Dose2021-04-11T08:00PT120M
17A123PCA200817Day 1A10COTININECotinineANALYTEPLASMA1ng/mL11ng/mL.0751DAY 112001-02-01T07:15145 MIN PREDOSE1Day 1 Dose2021-02-01T08:00-PT45M
18A123PCA200818Day 1A10NNNN'-NitrosonornicotineANALYTEPLASMA<0.1pg/mL<.3
pg/mL0.31DAY 112001-02-01T07:15145 MIN PREDOSE1Day 1 Dose2021-02-01T08:00-PT45M
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