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Bioequivalence Study of Rotigotine Transdermal Patch With Two Different Formulations in Healthy Japanese Subjects

NCT01565018 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2012-07-09

No results posted yet for this study

Summary

To investigate and compare the drug amount delivered to the body after each single administration of Rotigotine patch with 2 different formulations in healthy Japanese subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01565018 on ClinicalTrials.gov