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

NCT ID: NCT02070796

Last Updated: 2014-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-07-31

Brief Summary

The primary objective of the study is to establish Bioequivalence (BE) of 2 different formulations of the 2 mg/24 hr (10 cm^2) Rotigotine transdermal patches in Chinese subjects.

Detailed Description

Bioequivalence will be concluded if the 90 % Confidence Intervals (CIs) for the ratio Treatment A/Treatment B are fully included in the acceptance range from 0.8-1.25 for AUC(0-t) and AUC, and within the acceptance range from 0.7 to 1.43 for Cmax.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A - B

Single application of the test transdermal patch (Treatment A, Rotigotine PR2.2.1) for 24 hours, followed by a Wash-Out Period of 7 days and a single application of the reference transdermal patch (Treatment B, Rotigotine PR2.1.1) for 24 hours.

Group Type: EXPERIMENTAL

Rotigotine PR2.2.1

Intervention Type: DRUG

Treatment A:

Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Test drug product PR2.2.1. Single application of 1 patch for 24 hours.

Rotigotine PR2.1.1

Intervention Type: DRUG

Treatment B:

Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Reference drug product PR2.1.1. Single application of 1 patch for 24 hours.

Treatment B - A

Single application of the reference transdermal patch (Treatment B, Rotigotine PR2.1.1) for 24 hours, followed by a Wash-Out Period of 7 days and a single application of the test transdermal patch (Treatment A, Rotigotine PR2.2.1) for 24 hours.

Group Type: ACTIVE_COMPARATOR

Rotigotine PR2.2.1

Intervention Type: DRUG

Treatment A:

Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Test drug product PR2.2.1. Single application of 1 patch for 24 hours.

Rotigotine PR2.1.1

Intervention Type: DRUG

Treatment B:

Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Reference drug product PR2.1.1. Single application of 1 patch for 24 hours.

Interventions

Rotigotine PR2.2.1

Treatment A:

Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Test drug product PR2.2.1. Single application of 1 patch for 24 hours.

Intervention Type: DRUG

Rotigotine PR2.1.1

Treatment B:

Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Reference drug product PR2.1.1. Single application of 1 patch for 24 hours.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• An Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
• Subject is considered reliable and capable of adhering to the protocol, visit schedule, and patch application according to the judgment of the investigator
• Subject is willing and able to comply with all study requirements
• Subject is Chinese (with all 4 grandparents being of Chinese origin, as well), male, and aged between 18 and 40 years (inclusive)
• Subject is healthy (no clinically significant findings in any of the investigations at the Eligibility Assessment (EA))
• Subject has a body mass index between 19 kg/m² and 24 kg/m² (inclusive), and a body weight greater than or equal to 50 kg
• Subject agreed to practice a medically accepted method of contraception (eg, condom, spermicide) unless sexually abstinent for the duration of the study and up to 3 months after the final patch application

Exclusion Criteria

• Subject has previously participated in this study or subject has previously been assigned to treatment in a Rotigotine study
• Subject has participated in another study of an Investigational Medicinal Product (IMP) (or a medical device) within the previous 3 months or is currently participating in another study of an IMP (or a medical device)
• Subject has a history of diagnosis, counseling, or treatment for chronic alcohol or drug abuse within the previous 2 years
• Subject has a known clinically significant allergy or known or suspected clinically significant drug hypersensitivity to any components of the IMP or comparable drugs that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
• Subject has lifetime history of suicide attempt
• Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or has recently unresolved contact dermatitis
• Subject has an medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
• Subject has a history or present condition of epilepsy and/or seizures
• Subject has a history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Pharma SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

1

Hong Kong, , China

Countries

China

References

Liu Y, Tomlinson B, Guo J, Asgharnejad M, Bauer L, Surmann E, Guo X, Elshoff JP. Pharmacokinetics, Tolerability, and Bioequivalence of Two Formulations of Rotigotine in Healthy Chinese Subjects. Clin Ther. 2018 Jul;40(7):1108-1121.e8. doi: 10.1016/j.clinthera.2018.05.009.

Reference Type: DERIVED

PMID: 30098648 (View on PubMed)

Other Identifiers

PD0011

Identifier Type: -

Identifier Source: org_study_id