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Single-site, Open-label, Randomized, Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch Comparing 2 Different Formulations

NCT02070796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-07-29

No results posted yet for this study

Summary

The primary objective of the study is to establish Bioequivalence (BE) of 2 different formulations of the 2 mg/24 hr (10 cm\^2) Rotigotine transdermal patches in Chinese subjects.

Conditions

  • Healthy

Interventions

DRUG

Rotigotine PR2.2.1

Treatment A: Rotigotine Transdermal patch 2 mg/24 hr (10 cm\^2) Test drug product PR2.2.1. Single application of 1 patch for 24 hours.

DRUG

Rotigotine PR2.1.1

Treatment B: Rotigotine Transdermal patch 2 mg/24 hr (10 cm\^2) Reference drug product PR2.1.1. Single application of 1 patch for 24 hours.

Sponsors & Collaborators

  • UCB Pharma SA

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • China

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 NCT02070796 on ClinicalTrials.gov