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This is an example of a study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of nicotine pouches. Three nicotine Two different nicotine pouches products were used in the study. Each pouch product 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. 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, and 240 minutes after start of product use. ( Note: more time points may be used, these timepoints were used only for illustration).

(C_max), time to reach C_max (t_max), 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 (AUC_0-last) and (ii) from t₀ to 10 minutes after t₀ (AUC_0-10’). 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 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) of each visit from whose slope the elimination rate constant (k) was estimated and then used for the calculation of the baseline corrected values. . 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

Dataset wrap

Name	pc

Rowcaps

Rows 1-23:	Show the day 1 1 pre-dose drug and metabolite concentrations of nicotine 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.
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.	Rows 21-30:	Show additional drug and metabolite concentrations and specimen properties related to the day 11 dose.

Dataset2

NICO_PAR 2DRGADrug A Parent<01DAY 14515 MIM 0PT15M

Row	STUDYID	DOMAIN	USUBJID	PCSEQ	PCGRPID	PCREFID	PCTESTCD	PCTEST	PCCAT	PCSPEC	PCORRES	PCORRESU	PCSTRESC	PCSTRESN	PCSTRESU	PCSTAT	PCLLOQ	PCULOQ	VISITNUM	VISIT	VISITDY	PCDTCPCENDTC	PCDY	PCTPT	PCTPTNUM	PCTPTREF	PCRFTDTC	PCELTM	PCEVLINT
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	20		1	DAY 1	1	2001-02-01T07:4515	1	45MIN PREDOSE	01	Day 1 Dose	2001-02-01T08:00	-PT45M	NICOTINE PARENT
PLASMA	<1.0	30 MIN PREDOSE	-PT30M	2	ABC-123	PC	123-0001	2	Day	1	A554134-10	NICO_PAR	NICOTINE PARENT	ANALYTE	PLASMA	<1.0	ng/mL	<1.	0	ng/mL				0.10	20		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	3Day	3 Day 1	A554134-1110	DRGANICO_METPAR	NICOTINE PARENTDrug A Metabolite	ANALYTE	PLASMA	1<1.50	ng/mL	<2<0.1		ng/mL		20.0010	50020	1	DAY 1	1	2001-02-01T07:45	2001-02-01T07:45	12M	15 MIM PREDOSE	03	Day 1 Dose	2001-02-01T08:00	PT2M-PT15M
4	ABC-123	PC	123-0001	4Day	1Day 1	A554134-11	DRGANICO_PAR	Drug A ParentNICOTINE PARENT	ANALYTE	PLASMA	31.05	ng/mL	1.5	1.5<2	ng/mL		20.0010	500	1	DAY 1	1	2001-02-01T0701T08:452001-02-01T07:45	1	4M2M	04	Day 1 Dose	2001-02-01T08:00	PT$MPT2M
5	ABC-123	PC	123-0001	5	Day 1	A554134-11	VOLUME	Volume	NICO_PAR	NICOTINE PARENT	ANALYTESPECIMEN PROPERTY	PLASMA	83.0	ng/mL	100	100	3.0	3.0	ng/mL		0.10	500mL	1	DAY 1	1	2001-02-01T07:452001-02-01T07:4501T08:04	1	8M4M	05	Day 1 Dose	2001-02-01T08:00	PT8MPT4M
6	ABC-123	PC	123-0001	6	Day 1	A554134-11	PH	PH	NICO_PAR	NICOTINE PARENT	ANALYTESPECIMEN PROPERTY	PLASMA	58.0	ng/mL	8.0	5.5	8.0	ng/mL		0.105.5		1	DAY 1	1	2001-02-01T0701T08:45	2001-02-01T07:45	08	1	60M8M	06	Day 1 Dose	2001-02-01T08:00	PT60PT8M
7	ABC-123	PC	123-0001	7	Day 1	A554134-1211	DRGANICO_METPAR	NICOTINE PARENTDrug A Metabolite	ANALYTE	PLASMA	35.0.	ng/mL	5.40	5.40	ng/mL		0.10	20		1	DAY 1	1	2001-02-01T09:3000	1	120M60M	1.57	Day 1 Dose	2001-02-01T08:00	PT120PT60
8	ABC-123	PC	123-0001	8	Day 1	A554134-12	DRGANICO_PAR	Drug A ParentNICOTINE PARENT	ANALYTE	PLASMA	23.0 0	ng/mL	43.7404	3.740	ng/mL		0.10	20	1	DAY 1	1	2001-02-01T0901T010:3000	1	240M120M	1.58	Day 1 Dose	2001-02-01T08:00	PT240MPT120
9	ABC-123	PC	123-0001	9	Day 14	A554134-13	DRGANICO_METPAR	NICOTINE PARENTDrug A Metabolite	ANALYTE	PLASMA	5.44	ng/mL	5.44	5.44	ng/mL		0.10	20	12	DAY 141	4	2001-02-01T1404T107:0015	14	6H45MIN PREDOSE	61	Day 1 4 Dose	2001-02-01T0804T08:00	PT6H00M-PT45M
10	ABC-123	PC	123-0001	10	Day 14	A554134-13	DRGANICO_PAR	Drug A ParentNICOTINE PARENT	ANALYTE	PLASMA	1.09	ng/mL	1.09	1.09	ng/mL		0.10	20	12	DAY 141	4	2001-02-01T1404T07:0030	14	6H30MIN PREDOSE	62	Day 1 4 Dose	2001-02-01T0804T08:00	PT6H	11	ABC-123	PC	123-0001	11	Day 1	A554134-14	DRGA_MET	Drug A Metabolite	ANALYTE	PLASMA	NOT DONE	20	2	DAY 2	-PT30M
2	2001-02-02T08:00	2	24H	24	Day 1 Dose	2001-02-01T08:00	PT24H	12	ABC-123	PC	123-0001	1211	Day 14	A554134-14	DRGANICO_PAR	Drug A ParentNICOTINE PARENT	ANALYTE	PLASMA	<0.1	ng/mL	<0.1		ng/mL		0.10	20	2	DAY 242	4	2001-02-02T0804T07:0015	2424H	15 MIN REDOSE	243	Day 1 4 Dose	2001-02-01T0804T08:00	PT24H-PT15M
13	ABC-123	PC	123-0001	1312	Day 114	A554134-15	DRGANICO_METPART	NICOTINE PARENTDrug A Metabolite	ANALYTE	PLASMA	3.41	ng/mL	3.41	3.41	ng/mL		0.10	20	32	DAY 11411	4	2001-02-11T07:45	11	PREDOSE	0	04T08.02	4	2M	4	Day 4 Day 11 Dose	2001-02-11T0804T08:00-PT15M	PT2M
14	ABC-123	PC	123-0001	1413	Day 114	A554134-15	DRGANICO_PAR	Drug A ParentNICOTINE PARENT	ANALYTE	PLASMA	<0.1	ng/mL	<0.1		ng/mL		0.10	20	32	DAY 11411	4	2001-02-11T0704T08:4504	114	PREDOSE4M	05	Day 11 4 Dose	2001-02-11T0804T08:00-PT15M	PT4M
15	ABC-123	PC	123-0001	1514	Day 114	A554134-16	DRGANICO_METPAR	NICOTINE PARENTDrug A Metabolite	ANALYTE	PLASMA	8.74	ng/mL	8.74	8.74	ng/mL		0.10	20	32	DAY 11411	4	2001-02-11T0904T008.:3008	114	1H30MIN8M	1.56	Day 11 4 Dose	2001-02-11T0804T08:00	PT1H30MPT8M
16	ABC-123	PC	123-0001	1615	Day 114	A554134-16	DRGANICO_PAR	Drug A ParentNICOTINE PARENT	ANALYTE	PLASMA	4.2	ng/mL	4.2	4.2	ng/mL		0.10	20	32	DAY 11411	4	2001-02-11T0904T09:3000	114	1H30MIN60M	1.57	Day 11 4 Dose	2001-0204-11T08:00	PT1H30MPT160M
17	ABC-123	PC	123-0001	1716	Day 114	A554134-17	DRGANICO_METPAR	NICOTINE PARENTeDrug A Metabolite	ANALYTE	URINE	245	ng/mL	245	245	ng/mL	2.00	500	3	DAY 11	11	2001-02-11T08:00	2001-02-11T14:03	11	6H	6	Day 11 Dose	2001-02-11T08:00	PT6H	-PT6H	18	ABC-123	PC	123-0001	18	Day 11	A554134-17	DRGA_PAR	Drug A Parent	ANALYTE	URINE	13.1	ng/mL	13.1	13.1	ng/mL	2.00	500	3	DAY 11	11	2001-02-11T08:00	2001-02-11T14:03	11	6H	6	Day 11 Dose	2001-02-11T08:00	PT6H	-PT6H	19	ABC-123	PC	123-0001	19	Day 11	A554134-17	VOLUME	Volume	SPECIMEN PROPERTY	URINE	574	mL	574	574	mL	3	DAY 11	11	2001-02-11T08:00	2001-02-11T14:03	11	6H	6	Day 11 Dose	2001-02-11T08:00	PT6H	-PT6H	20	ABC-123	PC	123-0001	20	Day 11	A554134-17	PH	PH	SPECIMEN PROPERTY	URINE	5.5	5.5	5.5	3	DAY 11	11	2001-02-11T08:00	2001-02-11T14:03	11	6H	6	Day 11 Dose	2001-02-11T08:00	PT6H	-PT6H	21	ABC-123	PC	123-0001	21	Day 11	A554134-18	DRGA_MET	Drug A Metabolite	ANALYTE	PLASMA	9.02	ng/mL	9.02	9.02	ng/mL	0.10	20	3	DAY 11	11	2001-02-11T14:00	11	6H	6	Day 11 Dose	2001-02-11T08:00	PT6H	22	ABC-123	PC	123-0001	22	Day 11	A554134-18	DRGA_PAR	Drug A Parent	ANALYTE	PLASMA	1.18	ng/mL	1.18	1.18	ng/mL	0.10	20	3	DAY 11	11	2001-02-11T14:00	11	6H	6	Day 11 Dose	2001-02-11T08:00	PT6H	23	ABC-123	PC	123-0001	23	Day 11	A554134-19	DRGA_MET	Drug A Metabolite	ANALYTE	URINE	293	ng/mL	293	293	ng/mL	2.00	3	DAY 11	11	2001-02-11T14:03	2001-02-11T20:10	11	12H	12	Day 11 Dose	2001-02-11T08:00	PT12H	-PT6H	24	ABC-123	PC	123-0001	24	Day 11	A554134-19	DRGA_PAR	Drug A Parent	ANALYTE	URINE	7.1	ng/mL	7.1	7.1	ng/mL	2.00	3	DAY 11	11	2001-02-11T14:03	2001-02-11T20:10	11	12H	12	Day 11 Dose	2001-02-11T08:00	PT12H	-PT6H	25	ABC-123	PC	123-0001	25	Day 11	A554134-19	VOLUME	Volume	SPECIMEN PROPERTY	URINE	363	mL	363	363	mL	3	DAY 11	11	2001-02-11T14:03	2001-02-11T20:10	11	12H	12	Day 11 Dose	2001-02-11T08:00	PT12H	-PT6H	26	ABC-123	PC	123-0001	26	Day 11	A554134-19	PH	PH	SPECIMEN PROPERTY	URINE	5.5	5.5	5.5	3	DAY 11	11	2001-02-11T14:03	2001-02-11T20:10	11	12H	12	Day 11 Dose	2001-02-11T08:00	PT12H	-PT6H	500	2	DAY 4	4	2001-02-04T010:00	4	120M	8	Day 4 Dose	2001-04-11T08:00	PT120M	27	ABC-123	PC	123-0001	27	Day 11	A554134-20	DRGA_MET	Drug A Metabolite	ANALYTE	URINE	280	ng/mL	280	280	ng/mL	2.00	4	DAY 12	12	2001-02-11T20:03	2001-02-12T08:10	12	24H	24	Day 11 Dose	2001-02-11T08:00	PT24H	-PT12H	28	ABC-123	PC	123-0001	28	Day 11	A554134-20	DRGA_PAR	Drug A Parent	ANALYTE	URINE	2.4	ng/mL	2.4	2.4	ng/mL	2.00	4	DAY 12	12	2001-02-11T20:03	2001-02-12T08:10	12	24H	24	Day 11 Dose	2001-02-11T08:00	PT24H	-PT12H	29	ABC-123	PC	123-0001	29	Day 11	A554134-20	VOLUME	Volume	SPECIMEN PROPERTY	URINE	606	mL	606	606	mL	4	DAY 12	12	2001-02-11T20:03	2001-02-12T08:10	12	24H	24	Day 11 Dose	2001-02-11T08:00	PT24H	-PT12H	30	ABC-123	PC	123-0001	30	Day 11	A554134-20	PH	PH	SPECIMEN PROPERTY	URINE	5.5	5.5	5.5	4	DAY 12	12	2001-02-11T20:03	2001-02-12T08:10	12	24H	24	Day 11 Dose	2001-02-11T08:00	PT24H	-PT12H	31	ABC-123	PC	123-0001	31	Day 11	A554134-21	DRGA_MET	Drug A Metabolite	ANALYTE	PLASMA	3.73	ng/mL	3.73	3.73	ng/mL	0.10	20	4	DAY 12	12	2001-02-12T08:00	12	24H	24	Day 11 Dose	2001-02-11T08:00	PT24H	32	ABC-123	PC	123-0001	32	Day 11	A554134-21	DRGA_PAR	Drug A Parent	ANALYTE	PLASMA	<0.1	ng/mL	<0.1	ng/mL	0.10	20	4	DAY 12	12	2001-02-12T08:00	12	24H	24	Day 11 Dose	2001-02-11T08:00	PT24H

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