Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-04 @ 2:13 AM
Study NCT ID:
NCT02160067
Status:
COMPLETED
Last Update Posted:
2014-09-30
First Post:
2014-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Proportionality and Bioavailability Assessment of Buprenorphine Transdermal Delivery System Second Generation Patches
Sponsor:
Mundipharma Research Limited
Organization:
Study Overview
Official Title:
A Four-period, Randomised, Open-label, Crossover, Pharmacokinetic Study to Assess the Dose Proportionality and Relative Bioavailability of Buprenorphine Transdermal Delivery System Second Generation Patches Compared to First Generation Patches, in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2014-06
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 obtain pharmacokinetic data for a dose proportionality and relative bioavailability assessment of 2nd generation BTDS patches compared to 1st generation BTDS patches.
Detailed Description:
The objective is to examine a new 2nd generation BTDS patch formulation at 2 strengths: 3.15 mg and 12.6 mg, compared to 1st generation patches at 2 strengths: 5 mg and 20 mg, to assess dose proportionality and relative bioavailability before proceeding to a definitive program of studies. Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 288 hours post-patch application.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-000691-26 | EUDRACT_NUMBER | None | View |