Bioequivalence and Adhesion of a Rotigotine Patch in Healthy Subjects

NCT07769359 | Completed Phase 1

• 1 other identifier: C1B05695
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rotigotine patch adhesion and bioequivalence

Outcome Measures

Primary Outcomes (4)

• Bioequivalence based on Cmax

  Peak Plasma Concentration (Cmax) 90% confidence limits of T/R ratio must lie within 80-125 %

  24 Hours

• Non-Inferiority in Adhesion

  The Test patch adhesion 90% LCL must lie above 90%.

  24 Hours

• Bioequivalence based on AUC 0-t

  The area under the plasma concentration versus time curve (AUC 0-t) 90% confidence limits of T/R ratio must lie within 80-125 %

  24 Hours

• Bioequivalence based on AUCi

  The area under the plasma concentration versus time curve extrapolated to infinite (AUC i) 90% confidence limits of T/R ratio must lie within 80-125 %

  24 Hours

Study Arms (2)

Test / Reference

OTHER

Rotigotina B7 TDS (Test) / Neupro® (Reference)

Combination Product: Rotigotine Transdermal Delivery System (TDS)

Reference / Test

OTHER

Neupro® (Reference) / Rotigotina B7 TDS (Test)

Combination Product: Rotigotine Transdermal Delivery System (TDS)

Interventions

Rotigotine Transdermal Delivery System (TDS) COMBINATION_PRODUCT

Strength: 2 mg/24 hours

Reference / Test; Test / Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 55 years old, both inclusive.
• Gender: Male and/or non-pregnant, non-lactating female. A. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to first patch application. They must be using an acceptable form of contraception.
• B. For female of childbearing potential, acceptable forms of contraception include the following:
• i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.
• C. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
• i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level \> 40 mIU/mL, or iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iv. Total hysterectomy and an absence of bleeding for at least 3 months.
• BMI: 18.5 to 30.0 weight in kg/(height in meter)2 both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
• Non-alcoholic (i.e. having no past history of alcohol consumption for at least one year prior to study).
• Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study).
• Able to communicate effectively with study personnel.
• Willing to provide written informed consent to participate in the study.
• All participants must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first patch application of study which will include:
• A physical examination (clinical examination) with no clinically significant finding.
• Results within normal limits or clinically non-significant for the following tests:
• Hematology Hemoglobin Total RBC count Total WBC count Platelet count

You may not qualify if:

• Participants must not be enrolled in the study if they meet any one of the following criteria:
• History of allergic responses to Rotigotine, or any other components of the formulations (Test and/or Reference ones) or other related drugs and/or history of allergy to any adhesive materials.
• Have significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG, gynaecological history and examination (including pelvic examination and routine breast examination) (for female participants)\].
• Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
• History or presence of bronchial asthma.
• Use of any hormone replacement therapy within 3 months prior to the first patch application.
• A depot injection or implant of any drug within 3 months prior to the first patch application.
• Use of CYP enzyme inhibitors or inducers within 30 days prior to the first patch application (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
• History or evidence of narcotic abuse, drug dependence.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• A positive hepatitis screen (includes subtypes B \& C).
• A positive test result for HIV antibody.
• Participants who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first patch application.
• Participants who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or \>200 ml within 90 days (excluding volume drawn at screening for this study) prior to first patch application, whichever is greater.
• Intolerance to venipuncture

Sponsors & Collaborators

• Amarin Technologies S.A.U.: lead
• Cliantha Research Ltd.: collaborator

Study Sites (1)

Cliantha Research Ltd.

Vadodara, Gujarat, 390012, India

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Bioanalytical team members
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: evaluator-blinded, randomized, two-period, two-treatment, crossover, balanced, single dose.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 17, 2026
• Study Start: December 4, 2025
• Primary Completion: December 17, 2025
• Study Completion: February 26, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

IN (1)