MedTrace Logo

Bioequivalence and Adhesion of a Rotigotine Patch in Healthy Subjects

NCT07769359 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-08-19

No results posted yet for this study

Summary

This study was intended to demonstrate bioequivalence of the Amarin's Rotigotine patch respect to Neupro, (RLD), as well as non-inferiority in adhesion, when tested at a dose of 2 mg/24h in healthy subjects of both sexes. Local and systemic adverse events were also monitored and reported. Worn patches were recovered and analysed to compare residual drug.

Conditions

  • Bioequivalence
  • Adhesion
  • Adverse Effects

Interventions

COMBINATION_PRODUCT

Rotigotine Transdermal Delivery System (TDS)

Strength: 2 mg/24 hours

Sponsors & Collaborators

  • Cliantha Research Ltd.

    collaborator OTHER

  • Amarin Technologies S.A.U.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-12-04
Primary Completion
2025-12-17
Completion
2026-02-26

Countries

  • India

Study Locations

More Related Trials

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 NCT07769359 on ClinicalTrials.gov