Ignite Creation Date:
2024-05-06 @ 8:23 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02727205
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2016-02-25
Brief Title:
Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch
Sponsor:
Inflamax Research Incorporated
Organization:
Inflamax Research Incorporated
Study Overview
Official Title:
A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System 1 mg24 hr Versus Neupro Rotigotine Transdermal System 1 mg24 hr in Healthy 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:
STUDY TITLE
A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System 1 mg24 hr Versus Neupro Rotigotine Transdermal System 1 mg24 hr in Healthy Volunteers
TEST DRUG INVESTIGATIONAL PRODUCT
Rotigotine Transdermal System 1 mg24 hr
INDICATION STUDIED
Bioequivalence - Irritation and Sensitization
STUDY DESIGN
Multiple-site randomized multiple-application evaluator-blinded controlled study
One-half ½ of the test patch and one-half ½ of the reference patch was applied daily to the same site for each product over a 21 day period followed by a rest phase and a challenge phase
A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System 1 mg24 hr Versus Neupro Rotigotine Transdermal System 1 mg24 hr in Healthy Volunteers
TEST DRUG INVESTIGATIONAL PRODUCT
Rotigotine Transdermal System 1 mg24 hr
INDICATION STUDIED
Bioequivalence - Irritation and Sensitization
STUDY DESIGN
Multiple-site randomized multiple-application evaluator-blinded controlled study
One-half ½ of the test patch and one-half ½ of the reference patch was applied daily to the same site for each product over a 21 day period followed by a rest phase and a challenge phase
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