Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT04183634
Brief Summary:
The objective of this study is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.
Detailed Description:
The objective of this clinical trial is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.
The following evaluations will be assessed as "yes" or "no":
* Cold flow (dark ring formed around the patch)
* Patch movement/displacement
* Patch wrinkling
* Residue formation (at patch application on the release liner and at patch removal on the skin) Safety and tolerability of a single dose application of a patch containing 18 mg rotigotine (Test) against a patch containing 18 mg rotigotine (Reference) will be evaluated in terms of vital signs and AEs.
AEs and clinical tolerability will be monitored at all clinical trial visits. The safety evaluation will be based upon the review of the individual values (potentially clinically important abnormalities) and descriptive statistics (summary tables, graphics).
As additional safety parameters for the clinical trial physical examination findings, clinical laboratory parameters, and 12-lead ECGs will be assessed at the screening and follow-up.
Study:
NCT04183634
Study Brief:
Protocol Section:
NCT04183634