Ignite Creation Date:
2024-05-06 @ 12:26 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01574898
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2012-04-02
Brief Title:
Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations
Sponsor:
Pierre Fabre Medicament
Organization:
Pierre Fabre Medicament
Study Overview
Official Title:
Pilot Pharmacokinetic Study of Three New Nicotine Lozenge Formulations V0474 Versus Two Reference Formulations V0018 B mg and Niquitin Fresh Mint 4mg After Single Oral Administration in Healthy Male Smokers
Status:
COMPLETED
Status Verified Date:
2012-07
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 purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations V0474 in comparison with two reference products The clinical and biological safety of V0474 and the lozenge acceptability will also be assessed
Detailed Description:
None
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 |
|---|---|---|---|
| 2012-000419-94 | EUDRACT_NUMBER | None | None |