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1: Discuss the PCTEST and PCTESTCD Controlled Terminology. They are always measuring nicotine. 



This is an example of a study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of nicotine pouches. Three different nicotine pouches were used in the study. Each pouch was evaluated in 180 minute test session. AUC and CMAX were to be determined.    

The study consisted of a screening period, one day of admission, four separate days of on-site product use with 1–3 days in between each product use, and a 7-day safety follow-up period

45, 30, and 15 minutes prior start of product use and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after start of product use.

(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 using Phoenix WinNonlin (version 6.2, Pharsight Corp, Sunnyvale, California) and corrected for baseline following the method described by Kraiczi et al.30 whereby 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) of each visit from whose slope the elimination rate constant (k) was estimated and then used for the calculation of the baseline corrected values. 




Rows 1-2:Show day 1 pre-dose drug and metabolite concentrations in plasma and urine.
Rows 3-4:Show day 1 pre-dose drug and metabolite concentrations in urine. Urine specimens may be collected over an interval; both PCDTC and PCENDTC have been populated with the same value to indicate that these specimens were collected at a point in time rather than over an interval.
Rows 5-6:Show specimen properties (VOLUME and PH) for the day 1 pre-dose urine specimens. These have a PCCAT value of "SPECIMEN PROPERTY".
Rows 7-12:Show day 1 post-dose drug and metabolite concentrations in plasma.
Rows 13-16:Show day 11 drug and metabolite concentrations in plasma.
Rows 17-20:Show day 11 drug and metabolite concentrations in urine specimens collected over an interval. The elapsed times for urine samples are calculated as the elapsed time (from the reference time point, PCTPTREF) to the end of the specimen collection interval. Elapsed time values that are the same for urine and plasma samples have been assigned the same value for PCTPT. For the urine samples, the value in PCEVLINT describes the planned evaluation (or collection) interval relative to the time point. The actual evaluation interval can be determined by subtracting PCDTC from PCENDTC.
Rows 21-30:Show additional drug and metabolite concentrations and specimen properties related to the day 11 dose.
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pc.xpt

RowSTUDYIDDOMAINUSUBJIDPCSEQPCGRPIDPCREFIDPCTESTCDPCTESTPCCATPCSPECPCORRESPCORRESUPCSTRESCPCSTRESNPCSTRESUPCSTATPCLLOQPCULOQVISITNUMVISITVISITDYPCDTCPCENDTCPCDYPCTPTPCTPTNUMPCTPTREFPCRFTDTCPCELTMPCEVLINT
1ABC-123PC123-00011Day 1A554134-10NICO_PARNICOTINE PARENTANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.10201DAY 112001-02-01T07:45
145MIN  PREDOSE0Day 1 Dose2001-02-01T08:00-PT45M







NICO_PAR

NICOTINE PARENT



PLASMA<1.0












30 MIN PREDOSE


-PT30M
2ABC-123PC123-00012Day 2A554134-10DRGA_PARDrug A ParentANALYTEPLASMA<1.0ng/mL<0.1
ng/mL
0.10201DAY 112001-02-01T07:45
115 MIM PREDOSE0Day 1 Dose2001-02-01T08:00-PT15M
3ABC-123PC123-00013Day  3 A554134-11DRGA_METDrug A MetaboliteANALYTEPLASMA1.5ng/mL<2
ng/mL
2.005001DAY 112001-02-01T07:452001-02-01T07:4512M0Day 1 Dose2001-02-01T08:00PT2M
4ABC-123PC123-00014Day 1A554134-11DRGA_PARDrug A ParentANALYTEPLASMA3.0ng/mL<2
ng/mL
2.005001DAY 112001-02-01T07:452001-02-01T07:4514M0Day 1 Dose2001-02-01T08:00PT$M
5ABC-123PC123-00015Day 1A554134-11VOLUMEVolumeSPECIMEN PROPERTYPLASMA8.0mL100100mL


1DAY 112001-02-01T07:452001-02-01T07:4518M0Day 1 Dose2001-02-01T08:00PT8M
6ABC-123PC123-00016Day 1A554134-11PHPHSPECIMEN PROPERTYPLASMA5.0.
5.55.5



1DAY 112001-02-01T07:452001-02-01T07:45160M0Day 1 Dose2001-02-01T08:00PT60
7ABC-123PC123-00017Day 1A554134-12DRGA_METDrug A MetaboliteANALYTEPLASMA3.0ng/mL5.45.4ng/mL
0.10201DAY 112001-02-01T09:30
1120M1.5Day 1 Dose2001-02-01T08:00PT120
8ABC-123PC123-00018Day 1A554134-12DRGA_PARDrug A ParentANALYTEPLASMA2.0 ng/mL4.744.74ng/mL
0.10201DAY 112001-02-01T09:30
1240M1.5Day 1 Dose2001-02-01T08:00PT240M
9ABC-123PC123-00019Day 1A554134-13DRGA_METDrug A MetaboliteANALYTEPLASMA5.44ng/mL5.445.44ng/mL
0.10201DAY 112001-02-01T14:00
16H6Day 1 Dose2001-02-01T08:00PT6H00M
10ABC-123PC123-000110Day 1A554134-13DRGA_PARDrug A ParentANALYTEPLASMA1.09ng/mL1.091.09ng/mL
0.10201DAY 112001-02-01T14:00
16H6Day 1 Dose2001-02-01T08:00PT6H
11ABC-123PC123-000111Day 1A554134-14DRGA_METDrug A MetaboliteANALYTEPLASMA




NOT DONE
202DAY 222001-02-02T08:00
224H24Day 1 Dose2001-02-01T08:00PT24H
12ABC-123PC123-000112Day 1A554134-14DRGA_PARDrug A ParentANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.10202DAY 222001-02-02T08:00
224H24Day 1 Dose2001-02-01T08:00PT24H
13ABC-123PC123-000113Day 11A554134-15DRGA_METDrug A MetaboliteANALYTEPLASMA3.41ng/mL3.413.41ng/mL
0.10203DAY 11112001-02-11T07:45
11PREDOSE0Day 11 Dose2001-02-11T08:00-PT15M
14ABC-123PC123-000114Day 11A554134-15DRGA_PARDrug A ParentANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.10203DAY 11112001-02-11T07:45
11PREDOSE0Day 11 Dose2001-02-11T08:00-PT15M
15ABC-123PC123-000115Day 11A554134-16DRGA_METDrug A MetaboliteANALYTEPLASMA8.74ng/mL8.748.74ng/mL
0.10203DAY 11112001-02-11T09:30
111H30MIN1.5Day 11 Dose2001-02-11T08:00PT1H30M
16ABC-123PC123-000116Day 11A554134-16DRGA_PARDrug A ParentANALYTEPLASMA4.2ng/mL4.24.2ng/mL
0.10203DAY 11112001-02-11T09:30
111H30MIN1.5Day 11 Dose2001-02-11T08:00PT1H30M
17ABC-123PC123-000117Day 11A554134-17DRGA_METDrug A MetaboliteANALYTEURINE245ng/mL245245ng/mL
2.005003DAY 11112001-02-11T08:002001-02-11T14:03116H6Day 11 Dose2001-02-11T08:00PT6H-PT6H
18ABC-123PC123-000118Day 11A554134-17DRGA_PARDrug A ParentANALYTEURINE13.1ng/mL13.113.1ng/mL
2.005003DAY 11112001-02-11T08:002001-02-11T14:03116H6Day 11 Dose2001-02-11T08:00PT6H-PT6H
19ABC-123PC123-000119Day 11A554134-17VOLUMEVolumeSPECIMEN PROPERTYURINE574mL574574mL


3DAY 11112001-02-11T08:002001-02-11T14:03116H6Day 11 Dose2001-02-11T08:00PT6H-PT6H
20ABC-123PC123-000120Day 11A554134-17PHPHSPECIMEN PROPERTYURINE5.5
5.55.5



3DAY 11112001-02-11T08:002001-02-11T14:03116H6Day 11 Dose2001-02-11T08:00PT6H-PT6H
21ABC-123PC123-000121Day 11A554134-18DRGA_METDrug A MetaboliteANALYTEPLASMA9.02ng/mL9.029.02ng/mL
0.10203DAY 11112001-02-11T14:00
116H6Day 11 Dose2001-02-11T08:00PT6H
22ABC-123PC123-000122Day 11A554134-18DRGA_PARDrug A ParentANALYTEPLASMA1.18ng/mL1.181.18ng/mL
0.10203DAY 11112001-02-11T14:00
116H6Day 11 Dose2001-02-11T08:00PT6H
23ABC-123PC123-000123Day 11A554134-19DRGA_METDrug A MetaboliteANALYTEURINE293ng/mL293293ng/mL
2.00
3DAY 11112001-02-11T14:032001-02-11T20:101112H12Day 11 Dose2001-02-11T08:00PT12H-PT6H
24ABC-123PC123-000124Day 11A554134-19DRGA_PARDrug A ParentANALYTEURINE7.1ng/mL7.17.1ng/mL
2.00
3DAY 11112001-02-11T14:032001-02-11T20:101112H12Day 11 Dose2001-02-11T08:00PT12H-PT6H
25ABC-123PC123-000125Day 11A554134-19VOLUMEVolumeSPECIMEN PROPERTYURINE363mL363363mL


3DAY 11112001-02-11T14:032001-02-11T20:101112H12Day 11 Dose2001-02-11T08:00PT12H-PT6H
26ABC-123PC123-000126Day 11A554134-19PHPHSPECIMEN PROPERTYURINE5.5
5.55.5



3DAY 11112001-02-11T14:032001-02-11T20:101112H12Day 11 Dose2001-02-11T08:00PT12H-PT6H
27ABC-123PC123-000127Day 11A554134-20DRGA_METDrug A MetaboliteANALYTEURINE280ng/mL280280ng/mL
2.00
4DAY 12122001-02-11T20:032001-02-12T08:101224H24Day 11 Dose2001-02-11T08:00PT24H-PT12H
28ABC-123PC123-000128Day 11A554134-20DRGA_PARDrug A ParentANALYTEURINE2.4ng/mL2.42.4ng/mL
2.00
4DAY 12122001-02-11T20:032001-02-12T08:101224H24Day 11 Dose2001-02-11T08:00PT24H-PT12H
29ABC-123PC123-000129Day 11A554134-20VOLUMEVolumeSPECIMEN PROPERTYURINE606mL606606mL


4DAY 12122001-02-11T20:032001-02-12T08:101224H24Day 11 Dose2001-02-11T08:00PT24H-PT12H
30ABC-123PC123-000130Day 11A554134-20PHPHSPECIMEN PROPERTYURINE5.5
5.55.5



4DAY 12122001-02-11T20:032001-02-12T08:101224H24Day 11 Dose2001-02-11T08:00PT24H-PT12H
31ABC-123PC123-000131Day 11A554134-21DRGA_METDrug A MetaboliteANALYTEPLASMA3.73ng/mL3.733.73ng/mL
0.10204DAY 12122001-02-12T08:00
1224H24Day 11 Dose2001-02-11T08:00PT24H
32ABC-123PC123-000132Day 11A554134-21DRGA_PARDrug A ParentANALYTEPLASMA<0.1ng/mL<0.1
ng/mL
0.10204DAY 12122001-02-12T08:00
1224H24Day 11 Dose2001-02-11T08:00PT24H
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