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An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.

NCT04183634 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-11-09

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Sandoz · Sandoz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-03
Primary Completion
2020-03-16
Completion
2020-03-16

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

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 NCT04183634 on ClinicalTrials.gov