Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

In this study, subjects were randomized were randomized to either nicotine replacement patches or ENDsENDS devices using e-nicotine liquid cartridges. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS devicedevices. Subjects were requested not to smoke, but the number of regular cigarettes used were collected. Subject were seen every day for 15 days. The nicotine patch was applied at  , at rotating sites, and the ENDS nicotine cartridge was replaced every day. The cartridge was weight weighed when dispended dispensed and upon return.   On days, 1, 5, and 10 subjects remained in the clinic for 4 hours for collection of biomarkers.   On these days, the a new ENDS device was used for nicotine cartridge was inserted and 10 puffs were taken over 10 minutes, and then not used for 4 hours. The the remaining collection period. A new cartridge was inserted at the end of the 4-hour collection period. A nicotine replacement patch was applied prior to using the ENDS device on these days.        

The SU domain was used to represent the number of cigarettes used, but is not shown.  

In this study, the weight of the contents in the cartridge was tracked. The DA domain was used to represent dispensed and returned weights of each cartridge. Only a few rows are shown. The product accountability information was not provided for the nicotine replacement patches.    

Dataset wrap
Dataset2
RowSTUDYIDDOMAINUSUBJIDDASEQDAREFIDDATESTCDDATESTDACATDASCATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1TEDP07DA10001

1

CRT8754DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.3g2525g12004-06-06
2TEDP07DA10001

2

CRT8754RETAMTReturned AmountSTUDY PRODUCTE-LIQUID23g2323g12020-06-06
3TEDP07DA10001

3

CRT9756DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.1g2525g12020-06-07
4TEDP07DA10001

4

CRT9756RETAMTReturned AmountSTUDY PRODUCTE-LIQUID10g1414g22020-06-08
5TEDP07DA10001

5

CRT9955DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.2g2525g22004-06-08

EC was used to represent the collected exposure data since a double dummy -blind design was used. The EX domain  domain was used to represent the subject's exposure to the actual product contain nicotine.containing nicotine. The applicant represented each cartridge and patch used. The dose was represented as "1" to indicate 1 cartridge or patch. The actual date and specific time of usage of the cartridge was recorded on days 1, 5, and 10, while only the date of usage was recorded on other days.           

Dataset wrap
Nameec
TREATMENT
Dataset2

Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECTRT

ECDOSE

ECDOSTXT

ECDOSU

ECDOSFRM

ECROUTE

ECFREQ

ECLOCECLATECDIREPOCH

ECSTDTC

ECENDTC

1TEDP07EC10001 1ENDS  
1
10
CONTAINER

PUFF
INHALEDONCE
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-
01:8
01T08:002020-06-
01
01T08:
8:
10
2TEDP07EC10001 2

 PATCH 

1
PATCHPATCHTRANSDERMALARMRIGHTUPPER
TREATMENT
PRODUCT EXPOSURE2020-06-012020-06-02
3TEDP07EC10001 3ENDS 
1

AD LIBITUM
CONTAINER
PUFF
INHALEDAD LIBITUM
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE
TREATMENT
2020-06-
01:8
01T12:102020-06-02
4TEDP07EC10001 
1
4ENDS  
1

AD LIBITUM
CONTAINER
PUFF
INHALEDAD LIBITUMTREATMENT
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-022020-06-
02
03
5TEDP07EC10001
1
5
 PATCH 
PATCH 1
PATCHPATCHTRANSDERMALARMLEFTUPPER
TREATMENT
PRODUCT EXPOSURE2020-06-022020-06-03
6TEDP07EC10001
2
6ENDS 
1

AD LIBITUM
CONTAINER
PUFF
INHALEDAD LIBITUM
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE
TREATMENT
2020-06-032020-06-
03
04
7TEDP07EC10001
3
7
 PATCH 
PATCH 1
PATCHPATCHTRANSDERMALLEGLEFTUPPER
TREATMENT
PRODUCT EXPOSURE2020-06-032020-06-04
7TEDP07EC10001 
4
8ENDS 
1

AD LIBITUM
CONTAINER
PUFF
INHALEDAD LIBITUMTREATMENT
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-042020-06-05
8TEDP07EC10001 
5
9
 PATCH 
PATCH 1
PATCHPATCHTRANSDERMALLEGLEFTLOWER
TREATMENT
PRODUCT EXPOSURE2020-06-042020-06-05
9TEDP07EC10001
6
10ENDS 
1
10
CONTAINER

PUFF
INHALEDONCE
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE
TREATMENT
2020-06-
09;8
10T8:302020-06-
09;8
10T8:40
10TEDP07EC10001
7
11 PATCH 1
PATCH PATCH TRANSDERMALLEGRIGHTLOWER
TREATMENT
PRODUCT EXPOSURE2020-06-102020-06-11
11TEDP07EC10001
8
12ENDS 
1

AD LIBITUM
CONTAINER
PUFF
INHALEDAD LIBITUM
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE
TREATMENT
2020-06-
10:8
10T12:402020-06-11

 Subject 10001 was randomized to the 5% pharmaceutical strength of the nicotine e-liquid, and subject 20001 was randomized to the nicotine patch with a pharmaceutical strength of 14mg. The applicant only represented the active product exposure for each subject in EX.

Dataset wrap
Nameex
TREATMENT
Dataset2

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXFREQ

EXLOCEXLATEXDIREPOCH

EXPSTRG

EXPSTRGU

ECSTDTC

EXSTDTC

ECENDTC

EXENDTC

1TEDP07EX10001 1
ENDS  
e nicotine liquid 1.7
mg
g
INHALEDONCE
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-
01:8
01T08:002020-06-
01
01T:8:10
2TEDP07EX10001 2
ENDS 46mgINHALEDAD LIBITUM
e nicotine liquid 15.1gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%
TREATMENT
2020-06-
01:8
01T12:102020-06-02
3TEDP07EX10001 3
ENDS  45mgINHALEDAD LIBITUM
e nicotine liquid 13gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%
TREATMENT
2020-06-022020-06-
02
03
4TEDP07EX100014
ENDS 35mgINHALEDAD LIBITUM
e nicotine liquid 12gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%
TREATMENT
2020-06-032020-06-
03
04
5TEDP07EX10001 5
ENDS 35mgINHALEDAD LIBITUM
e nicotine liquid 9gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%
TREATMENT
2020-06-042020-06-05
6TEDP07EX100016
ENDS 45mgINHALEDONCE
e nicotine liquid 7gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%
TREATMENT
2020-06-
09;8
10T08:302020-06-
09;8
10T08:40
7TEDP07EX100017
ENDS 46mgINHALEDAD LIBITUM
e nicotine liquid 5gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%
TREATMENT
2020-06-
10:8
10T12:402020-06-11
8TEDP07
EC
EX
10001 
20001 1
 PATCH 

nicotine replacement therapy

1PATCHPATCHTRANSDERMAL
QD
ARMRIGHTUPPER
TREATMENT
PRODUCT EXPOSURE14mg2020-06-012020-06-02
9TEDP07
EC
EX200012
 PATCH 
nicotine replacement therapy1PATCHPATCHTRANSDERMAL
QD
ARMLEFTUPPER
TREATMENT
PRODUCT EXPOSURE14mg2020-06-022020-06-03
10TEDP07
EC
EX200013
 PATCH 
nicotine replacement therapy1PATCHPATCHTRANSDERMAL
QD
LEGLEFTUPPER
TREATMENT
PRODUCT EXPOSURE14mg2020-06-032020-06-04
11TEDP07
EC
EX20001 4
 PATCH 
nicotine replacement therapy1PATCHPATCHTRANSDERMAL
QD
LEGLEFTLOWER
TREATMENT
PRODUCT EXPOSURE14mg2020-06-042020-06-05
12TEDP07
EC
EX20001
7
5
 PATCH 
nicotine replacement therapy1PATCH PATCHTRANSDERMAL
QD
LEGRIGHTLOWER
TREATMENT
PRODUCT EXPOSURE14mg2020-06-102020-06-11