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Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in Healthy Korean Subjects

NCT01964573 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-10-20

No results posted yet for this study

Summary

The objective of this trial is to investigate the PK (Pharmacokinetic) of repeated-dose applications of the Rotigotine transdermal patch in healthy young male and female Korean subjects to be submitted to MFDS for new drug application approval.

Conditions

Interventions

DRUG

Rotigotine

Day 1-3: 2 mg patch once daily Day 4-6: 4 mg patch once daily

OTHER

Placebo

Placebo patches matching with Rotigotine 2 mg patches and 4 mg patches. Frequency: Day 1-3: 2 mg patch once daily Day 4-6: 4 mg patch once daily

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB, Inc. · +1 877 822 9493

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT01964573 on ClinicalTrials.gov