Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of two Rotigotine patches of two different formulations

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.

NCT00881894

Healthy

COMPLETED PHASE1

Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body

NCT00957944

Healthy Volunteers

COMPLETED PHASE1

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

NCT01565018

Healthy Volunteers

COMPLETED PHASE1

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

Healthy

COMPLETED PHASE1

A Study of Seltorexant in Healthy Participants

NCT04553042

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rotigotine PR2.2.1 first

Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days

Group Type EXPERIMENTAL

Rotigotine transdermal patch

Intervention Type DRUG

Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours

Rotigotine PR2.1.1 first

Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days

Group Type EXPERIMENTAL

Rotigotine transdermal patch

Intervention Type DRUG

Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rotigotine transdermal patch

Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neupro®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy White, male volunteers between 18 and 55 years of age (inclusive).
* BMI between 19 and 28 kg/m\^2 (inclusive)

Exclusion Criteria

* Previous participation in a clinical study with Rotigotine
* History or current condition of epilepsy and/or seizures
* Known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity
* History of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis
* History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease
* Clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations
* Positive HIV, hepatitis B or C test or positive alcohol or drug test
* Relevant hepatic or renal dysfunction
* Intake of medication that might interfere with the test drug within 2 weeks prior to dosing

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes