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Completed

NCT Number: NCT02070796

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

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotigotine PR2.2.1

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

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.

Primary outcomes

  1. Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration (AUC(0-t))

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application.

  2. Area under the plasma concentration-time curve from zero up to Infinity (AUC)

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  3. The maximum plasma concentration of unconjugated Rotigotine (Cmax)

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

Secondary outcomes

  1. Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg) (AUC(0-t) norm (apparent dose))

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  2. Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg) (AUC(0-t) norm (BW))

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  3. Area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg) (AUCnorm (apparent dose))

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  4. Area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg) (AUCnorm (BW))

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  5. Maximum plasma concentration of unconjugated Rotigotine normalized by apparent dose (Cmax, norm (apparent dose))

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  6. Maximum plasma concentration of unconjugated Rotigotine normalized by body weight (Cmax, norm (BW))

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  7. Time to reach a maximum plasma concentration of unconjugated Rotigotine after patch application (tmax)

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  8. Mean residence time (MRT)

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  9. Rate constant of elimination (λz)

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  10. Terminal half-life (t1/2)

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  11. Relative bioavailability calculated based on Cmax (fCmax)

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  12. Relative bioavailability calculated based on AUC (fAUC)

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

  13. Apparent total body clearance (CL/f)

    Time frame: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

Sponsors and collaborators

Lead sponsor

UCB Pharma SA

Industry

Registry information

Official study title

Single-site, Open-label, Randomized, Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch (2 mg/24 h) Comparing 2 Different Formulations

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 25, 2014
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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