An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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":
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Cold flow (dark ring formed around the patch)
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Patch movement/displacement
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Patch wrinkling
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference) For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h |
Drug: Rotigotine TTS (Test)
Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.
Drug: Neupro (Reference)
Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.
|
| Active Comparator: Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test) For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h |
Drug: Rotigotine TTS (Test)
Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.
Drug: Neupro (Reference)
Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.
|
Outcome Measures
Primary Outcome Measures
- Patch Adhesion [24 hours in each Treatment Period]
Patch Adhesion will be measured as the percentage of area that remained adhered after 24 hours of patch application.
Secondary Outcome Measures
- Number of patients with cold flow [24 hours in each Treatment Period]
Cold flow is defined as dark ring formed around the patch
- Number of patients with patch movement/displacement [24 hours in each Treatment Period]
- Number of patients with patch wrinkling [24 hours in each Treatment Period]
- Number of patients with patch residue formation [24 hours in each Treatment Period]
Patch residue formation is assessed at patch application on the release liner and at patch removal on the skin.
Eligibility Criteria
Criteria
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:
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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
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History or presence of clinically significant dermatologic diseases or conditions, such as atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma.
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History or presence of any dermatological condition or skin sensitivity that could affect IMP Absorption
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sandoz Investigative Site | Hamburg | Germany |
Sponsors and Collaborators
- Sandoz
Investigators
- Study Director: Sandoz, Sandoz
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-06-TTS-10