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An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.

2019-12-09 00:56:35 | BioPortfolio

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.

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 Design

Conditions

Parkinson Disease

Intervention

Rotigotine TTS (Test), Neupro (Reference)

Location

Sandoz Investigative Site
Hamburg
Germany

Status

Not yet recruiting

Source

Sandoz

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-12-09T00:56:35-0500

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