Bioequivalence Study of Rotigotine Transdermal Patch With Two Different Formulations in Healthy Japanese Subjects
NCT ID: NCT01565018
Last Updated: 2012-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
55 participants
INTERVENTIONAL
2012-03-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Treatment A - Treatment B
Treatment A: Test; drug product PR 2.2.1
Treatment B: Reference; drug product PR 2.1.4
Sequence of two single applications of Rotigotine transdermal patches (PR 2.2.1 first) for 24 hours separated by a Washout Period of 5 days.
Rotigotine PR 2.1.4
Treatment B: Rotigotine transdermal patch (2 mg/24 h \[10 cm\^2\]). Reference; drug product PR 2.1.4. Single application of 1 patch for 24 hours.
Rotigotine PR 2.2.1
Treatment A: Rotigotine transdermal patch (2 mg/24 h \[10 cm\^2\]). Test; drug product PR 2.2.1. Single application of 1 patch for 24 hours.
Treatment B - Treatment A
Treatment B: Reference; drug product PR 2.1.4
Treatment A: Test; drug product PR 2.2.1
Sequence of two single applications of Rotigotine transdermal patches (PR 2.1.4 first) for 24 hours separated by a Washout Period of 5 days.
Rotigotine PR 2.1.4
Treatment B: Rotigotine transdermal patch (2 mg/24 h \[10 cm\^2\]). Reference; drug product PR 2.1.4. Single application of 1 patch for 24 hours.
Rotigotine PR 2.2.1
Treatment A: Rotigotine transdermal patch (2 mg/24 h \[10 cm\^2\]). Test; drug product PR 2.2.1. Single application of 1 patch for 24 hours.
Interventions
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Rotigotine PR 2.1.4
Treatment B: Rotigotine transdermal patch (2 mg/24 h \[10 cm\^2\]). Reference; drug product PR 2.1.4. Single application of 1 patch for 24 hours.
Rotigotine PR 2.2.1
Treatment A: Rotigotine transdermal patch (2 mg/24 h \[10 cm\^2\]). Test; drug product PR 2.2.1. Single application of 1 patch for 24 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
* Subject has a QTcB (QT interval corrected for Heart Rate \[HR\] using Bazett´s formula) interval of ≥ 430 ms (≥ 450 ms for females) or any other clinically relevant finding in Electrocardiogram (ECG) at the Eligibility Assessment (EA)
* Subject is having clinically relevant allergy or clinically relevant drug hypersensitivity to any components of the Investigational Medical Product (IMP), or/and having an atopic or eczematous Dermatitis, Psoriasis and/or active skin disease
* Subject has a recent history (within 2 years) of chronic alcohol or drug abuse and has a history of significant skin hypersensitivity to transdermal products, and of an atopic or eczematous Dermatitis, Psoriasis, and/or active skin disease and have a history of suicide attempt, Epilepsy and/or seizures
* Subject has made a blood donation or a comparable blood loss within the last 3 months prior to the Eligibility Assessment (EA)
* Subject is pregnant or nursing
20 Years
55 Years
ALL
Yes
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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1
Neuss, , Germany
Countries
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Other Identifiers
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2011-004851-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PD0002
Identifier Type: -
Identifier Source: org_study_id