This is an example of a crossover study testing 7 smokeless tobacco products. All products contain nicotine except for product F, which was a nicotine/tobacco free product. Each subject first used the product ad libitum and the next day the product usage was evaluated in the morning, as specified in the protocol. The subjects were confined to the site. Products were supplied to the subjects as needed by site staff. Each usage was recorded. The applicant did not submit a Product Accountability (DA) domain, nor an EC domain. The name of the "actual product" would be used but a dummy name was used in the example below.
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Row STUDYID DOMAIN USUBJID EXSEQ EXTRT EXCAT EXDOSE EXDOSU EXDOSFRM EXROUTE EXPSTRG EXPSTRGU VISITNUM VISIT VISITDY EPOCH EXSTDTC EXENDTC 1 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 1 PRODUCT C UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 6 mg 10 DAY -1 -1 PRODUCT EXPOSURE 2019-06-27T13:10:33 2019-06-27T13:38:49 2 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 2 PRODUCT C UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 6 mg 10 DAY -1 -1 PRODUCT EXPOSURE 2019-06-27T14:29:13 2019-06-27T14:54:53 3 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 3 PRODUCT C CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 6 mg 11 DAY 1 1 PRODUCT EXPOSURE 2019-06-28T08:00:12 2019-06-28T08:30:21 4 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 4 PRODUCT E UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 4 mg 11 DAY 1 1 PRODUCT EXPOSURE 2019-06-28T14:01:52 2019-06-28T14:55:27 5 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 5 PRODUCT E UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 4 mg 11 DAY 1 1 PRODUCT EXPOSURE 2019-06-28T15:18:35 2019-06-28T15:57:33 6 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 6 PRODUCT E CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 4 mg 12 DAY 2 2 PRODUCT EXPOSURE 2019-06-29T08:00:08 2019-06-29T08:30:13 7 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 7 PRODUCT B UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 2 mg 12 DAY 2 2 PRODUCT EXPOSURE 2019-06-29T14:01:50 2019-06-29T14:50:11 8 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 8 PRODUCT B UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 2 mg 12 DAY 2 2 PRODUCT EXPOSURE 2019-06-29T15:24:33 2019-06-29T15:59:46 9 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 9 PRODUCT B CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 2 mg 13 DAY 3 3 PRODUCT EXPOSURE 2019-06-30T08:00:00 2019-06-30T08:30:00 10 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 10 PRODUCT D UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 6 mg 13 DAY 3 3 PRODUCT EXPOSURE 2019-06-30T14:12:32 2019-06-30T14:47:47 11 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 11 PRODUCT D UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 6 mg 13 DAY 3 3 PRODUCT EXPOSURE 2019-06-30T15:24:46 2019-06-30T16:04:57 12 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 12 PRODUCT D CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 6 mg 14 DAY 4 4 PRODUCT EXPOSURE 2019-07-01T08:00:00 2019-07-01T08:30:00 13 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 13 PRODUCT A UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 8 mg 14 DAY 4 4 PRODUCT EXPOSURE 2019-07-01T14:02:36 2019-07-01T14:47:33 14 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 14 PRODUCT A UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 8 mg 14 DAY 4 4 PRODUCT EXPOSURE 2019-07-01T15:37:45 2019-07-01T15:58:15 15 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 15 PRODUCT A CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 8 mg 15 DAY 5 5 PRODUCT EXPOSURE 2019-07-02T08:00:00 2019-07-02T08:30:01 16 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 16 PRODUCT F UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 0 mg 15 DAY 5 5 PRODUCT EXPOSURE 2019-07-02T14:11:00 2019-07-02T14:54:08 17 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 17 PRODUCT F UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 0 mg 15 DAY 5 5 PRODUCT EXPOSURE 2019-07-02T15:38:52 2019-07-02T15:59:50 18 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 18 PRODUCT F CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 0 mg 16 DAY 6 6 PRODUCT EXPOSURE 2019-07-03T08:00:00 2019-07-03T08:30:00 19 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 19 PRODUCT G UNCONTROLLED PRODUCT USE 3.37 g QUID ORAL 4 mg 16 DAY 6 6 PRODUCT EXPOSURE 2019-07-03T14:13:14 2019-07-03T14:57:40 20 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 20 PRODUCT G UNCONTROLLED PRODUCT USE 3.2 g QUID ORAL 4 mg 16 DAY 6 6 PRODUCT EXPOSURE 2019-07-03T15:35:01 2019-07-03T16:07:25 21 ALCS-REG-STUDY EX ALCS-REG-STUDY_10001 21 PRODUCT G CONTROLLED PRODUCT USE 2 g QUID ORAL 4 mg 17 DAY 7/EARLY TERMINATION 7 PRODUCT EXPOSURE 2019-07-04T08:00:04 2019-07-04T08:30:05 22 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 1 PRODUCT E UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 8 mg 10 DAY -1 -1 PRODUCT EXPOSURE 2019-07-04T14:06:09 2019-07-04T14:14:14 23 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 2 PRODUCT E CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 8 mg 11 DAY 1 1 PRODUCT EXPOSURE 2019-07-05T08:00:00 2019-07-05T08:30:00 24 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 3 PRODUCT D UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 4 mg 11 DAY 1 1 PRODUCT EXPOSURE 2019-07-05T14:02:39 2019-07-05T14:18:57 25 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 4 PRODUCT D CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 4 mg 12 DAY 2 2 PRODUCT EXPOSURE 2019-07-06T08:00:00 2019-07-06T08:30:00 26 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 5 PRODUCT C UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 6 mg 12 DAY 2 2 PRODUCT EXPOSURE 2019-07-06T14:00:00 2019-07-06T14:08:40 27 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 6 PRODUCT C UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 6 mg 12 DAY 2 2 PRODUCT EXPOSURE 2019-07-06T15:52:53 2019-07-06T15:59:21 28 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 7 PRODUCT C CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 6 mg 13 DAY 3 3 PRODUCT EXPOSURE 2019-07-07T08:00:00 2019-07-07T08:30:00 29 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 8 PRODUCT F UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 2 mg 13 DAY 3 3 PRODUCT EXPOSURE 2019-07-07T14:01:12 2019-07-07T14:12:25 30 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 9 PRODUCT F UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 0 mg 13 DAY 3 3 PRODUCT EXPOSURE 2019-07-07T14:57:49 2019-07-07T15:07:07 31 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 10 PRODUCT F CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 0 mg 14 DAY 4 4 PRODUCT EXPOSURE 2019-07-08T08:00:00 2019-07-08T08:30:00 32 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 11 PRODUCT B UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 0 mg 14 DAY 4 4 PRODUCT EXPOSURE 2019-07-08T14:00:52 2019-07-08T14:17:31 33 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 12 PRODUCT B UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 2 mg 14 DAY 4 4 PRODUCT EXPOSURE 2019-07-08T14:46:07 2019-07-08T14:53:43 34 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 13 PRODUCT B CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 2 mg 15 DAY 5 5 PRODUCT EXPOSURE 2019-07-09T08:00:01 2019-07-09T08:30:01 35 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 14 PRODUCT G UNCONTROLLED PRODUCT USE 2.69 g QUID ORAL 4 mg 15 DAY 5 5 PRODUCT EXPOSURE 2019-07-09T14:06:24 2019-07-09T14:30:16 36 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 15 PRODUCT G UNCONTROLLED PRODUCT USE 3.3 g QUID ORAL 4 mg 15 DAY 5 5 PRODUCT EXPOSURE 2019-07-09T14:49:39 2019-07-09T15:15:16 37 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 16 PRODUCT G CONTROLLED PRODUCT USE 2 g QUID ORAL 4 mg 16 DAY 6 6 PRODUCT EXPOSURE 2019-07-10T08:00:00 2019-07-10T08:30:00 38 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 17 PRODUCT A UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 8 mg 16 DAY 6 6 PRODUCT EXPOSURE 2019-07-10T14:02:07 2019-07-10T14:35:40 39 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 18 PRODUCT A UNCONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 8 mg 16 DAY 6 6 PRODUCT EXPOSURE 2019-07-10T15:27:37 2019-07-10T15:58:24 40 ALCS-REG-STUDY EX ALCS-REG-STUDY_10002 19 PRODUCT A CONTROLLED PRODUCT USE 1 POUCH POUCH ORAL 8 mg 17 DAY 7/EARLY TERMINATION 7 PRODUCT EXPOSURE 2019-07-11T08:00:00 2019-07-11T08:30:00
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