Ignite Creation Date:
2024-05-06 @ 1:44 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01887847
Status:
COMPLETED
Last Update Posted:
2016-03-30
First Post:
2013-06-13
Brief Title:
Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge
Sponsor:
Pharmaceutical Productions Inc
Organization:
Pharmaceutical Productions Inc
Study Overview
Official Title:
A Randomized 2 Way Crossover Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablets Pharmaceutical Productions Inc Versus COMMIT Smoking Lozenge GLAXOSMITHKLINE in Healthy Smoking Volunteers
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to compare the pharmacokinetics of an investigational 2 mg sublingual nicotine tablet Pharmaceutical Productions Inc to a 2 mg Commit nicotine lozenge GlaxoSmith Kline in a randomized crossover design in 6 male and female otherwise healthy smokers
Detailed Description:
A single oral dose of each medication will be administered to each participant with a 48 hour washout period between administrations Serial blood samples will be obtained at the following times after the administration of the nicotine dosage forms 0 4 8 10 12 16 30 45 60 90 120 and 180 minutes Vital signs will be obtained prior to dosing and at 30 60 180 and 240 minutes after dosage administration A craving questionnaire will be administered prior to dosing and at 5 11 17 25 35 50 and 65 minutes Craving questionnaires will then be administered at 30 minute intervals thereafter up to 180 minutes after medication administration A Product Preference Questionnaire will be completed at the end of the second study period A 30 day follow-up visit will be scheduled with each participant at the conclusion of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R41DA033710 | NIH | None | httpsreporternihgovquickSearchR41DA033710 |