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

Phase 1TerminatedNCT04183634

Sandoz31 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

Rotigotine TTS (Test)DRUG

Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.

Neupro (Reference)DRUG

Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients diagnosed with idiopathic Parkinson's Disease assessed as eligible for receiving 18 mg/IRR 8 mg/24 h rotigotine via the test and the reference product each on subsequent days in order to reach the dose of active substance at the individual routine medical care. Patients should be on a stable rotigotine dose of at least 8 mg/24 h for at least 1 week before screening. Exclusion Criteria: * Current participation in another clinical trial, participation in another clinical study (i.e. last protocol specified visit) involving another IMP within at least 28 days prior to first application or previous participation in this clinical Trial * History or presence of clinically significant dermatologic diseases or conditions, such as atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma. * History or presence of any dermatological condition or skin sensitivity that could affect IMP Absorption * History of clinically relevant (severe) hypersensitivity to the active pharmaceutical ingredient or substances of the same class or one of the excipients, clinically relevant allergy.

Locations (1)

Sandoz Investigative Site

Hamburg, Germany

Outcomes

Primary Outcomes

Patch Adhesion

Patch Adhesion will be measured as the percentage of area that remained adhered after 24 hours of patch application.