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. There was 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. (More time points were used, these timepoints 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
pc.xpt
Row
STUDYID
DOMAIN
USUBJID
PCSEQ
PCGRPID
PCREFID
PCTESTCD
PCTEST
PCCAT
PCSPEC
PCORRES
PCORRESU
PCSTRESC
PCSTRESN
PCSTRESU
PCSTAT
PCLLOQ
VISITNUM
VISIT
VISITDY
PCDTC
PCDY
PCTPT
PCTPTNUM
PCTPTREF
PCRFTDTC
PCELTM
1
ABC-123
PC
123-0001
1
Day 1
A10
NICOTNE
Nicotine
ANALYTE
PLASMA
<0.1
ng/mL
<0.1
ng/mL
0.10
1
DAY 1
1
2001-02-01T07:15
1
45 MIN PREDOSE
1
Day 1 Dose
2001-02-01T08:00
-PT45M
2
ABC-123
PC
123-0001
2
Day 1
A11
NICOTINE
Nicotine
ANALYTE
PLASMA
<1.0
ng/mL
<1.0
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
ANALYTE
PLASMA
<1.0
ng/mL
<0.1
ng/mL
0.10
1
DAY 1
1
2001-02-01T07:45
1
15 MIN PREDOSE
3
Day 1 Dose
2001-02-01T08:00
-PT15M
4
ABC-123
PC
123-0001
4
Day1
A13
NICOTINE
Nicotine
ANALYTE
PLASMA
1.5
ng/mL
1.5
1.5
ng/mL
0.10
1
DAY 1
1
2001-02-01T08:02
1
2 MIN
4
Day 1 Dose
2001-02-01T08:00
PT2M
5
ABC-123
PC
123-0001
5
Day 1
A14
NICOTINE
Nicotine
ANALYTE
PLASMA
3.0
ng/mL
3.0
3.0
ng/mL
0.10
1
DAY 1
1
2001-02-01T08:04
1
4 MIN
5
Day 1 Dose
2001-02-01T08:00
PT4M
6
ABC-123
PC
123-0001
6
Day 1
A15
NICOTINE
Nicotine
ANALYTE
PLASMA
8.0
ng/mL
8.0
8.0
ng/mL
0.10
1
DAY 1
1
2001-02-01T08:08
1
8 MIN
6
Day 1 Dose
2001-02-01T08:00
PT8M
7
ABC-123
PC
123-0001
7
Day 1
A16
NICOTINE
Nicotine
ANALYTE
PLASMA
5.0.
ng/mL
5.0
5.0
ng/mL
0.10
1
DAY 1
1
2001-02-01T09:00
1
60 MIN
7
Day 1 Dose
2001-02-01T08:00
PT60
8
ABC-123
PC
123-0001
8
Day 1
A16
NICOTINE
Nicotine
ANALYTE
PLASMA
3.0
ng/mL
3.0
3.0
ng/mL
0.10
1
DAY 1
1
2001-02-01T010:00
1
120 MIN
8
Day 1 Dose
2001-02-01T08:00
PT120
9
ABC-123
PC
123-0001
9
Day 4
A17
NICOTINE
Nicotine
ANALYTE
PLASMA
5.44
ng/mL
5.44
5.44
ng/mL
0.10
2
DAY 4
4
2001-02-04T107:15
4
45 MIN PREDOSE
1
Day 4 Dose
2001-02-04T08:00
-PT45M
10
ABC-123
PC
123-0001
10
Day 4
A18
NICOTINE
Nicotine
ANALYTE
PLASMA
1.09
ng/mL
1.09
1.09
ng/mL
0.10
2
DAY 4
4
2001-02-04T07:30
4
30 MIN PREDOSE
2
Day 4 Dose
2001-02-04T08:00
-PT30M
11
ABC-123
PC
123-0001
11
Day 4
A19
NICOTINE
Nicotine
ANALYTE
PLASMA
<0.1
ng/mL
<0.1
ng/mL
0.10
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
NICOTINE
Nicotine
ANALYTE
PLASMA
3.41
ng/mL
3.41
3.41
ng/mL
0.10
2
DAY 4
4
2001-02-04T08.02
4
2 MIN
4
Day 4 Dose
2001-02-04T08:00
PT2M
13
ABC-123
PC
123-0001
13
Day 4
A21
NICOTINE
Nicotine
ANALYTE
PLASMA
<0.1
ng/mL
<0.1
ng/mL
0.10
2
DAY 4
4
2001-02-04T08:04
4
4 MIN
5
Day 4 Dose
2001-02-04T08:00
PT4M
14
ABC-123
PC
123-0001
14
Day 4
A22
NICOTINE
Nicotine
ANALYTE
PLASMA
8.74
ng/mL
8.74
8.74
ng/mL
0.10
2
DAY 4
4
2001-02-04T008.:08
4
8 MIN
6
Day 4 Dose
2001-02-04T08:00
PT8M
15
ABC-123
PC
123-0001
15
Day 4
A23
NICOTINE
Nicotine
ANALYTE
PLASMA
4.2
ng/mL
4.2
4.2
ng/mL
0.10
2
DAY 4
4
2001-02-04T09:00
4
60 MIN
7
Day 4 Dose
2001-04-11T08:00
PT160M
16
ABC-123
PC
123-0001
16
Day 4
A24
NICOTINE
Nicotine
ANALYTE
PLASMA
245
ng/mL
245
245
ng/mL
0.10
2
DAY 4
4
2001-02-04T010:00
4
120 MIN
8
Day 4 Dose
2001-04-11T08:00
PT120M
17
ABC-123
PC
123-0001
17
Day 1
A10
COTININE
Cotinine
ANALYTE
PLASMA
1
ng/mL
1
1
ng/mL
.075
1
DAY 1
1
2001-02-01T07:15
1
45 MIN PREDOSE
1
Day 1 Dose
2001-02-01T08:00
-PT45M
18
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
45 MIN PREDOSE
1
Day 1 Dose
2001-02-01T08:00
-PT45M
Dataset Debug Message
There are four leading, trailing, or non-breaking spaces in the dataset.