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

NCT01565018 | Completed Phase 1

• 2 other identifiers: PD00022011-004851-38
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate and compare the drug amount delivered to the body after each single administration of Rotigotine patch with 2 different formulations in healthy Japanese subjects.

Conditions

Healthy Volunteers

Keywords

Rotigotine; Neupro®; Transdermal Patch; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration of unconjugated Rotigotine (Cmax)

  The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.

  Pharmacokinetic (PK) samples will be taken predose, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h and 48 h after Rotigotine administration

• Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration of unconjugated Rotigotine (AUC 0-t)

  Pharmacokinetic (PK) samples will be taken predose, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h and 48 h after Rotigotine administration

Secondary Outcomes (14)

• Area under the plasma concentration-time curve from zero up to infinity (AUC(0-∞))

  Pharmacokinetic (PK) samples will be taken predose, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h and 48 h after Rotigotine administration

• 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))

  Pharmacokinetic (PK) samples will be taken predose, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h and 48 h after Rotigotine administration

• 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))

  Pharmacokinetic (PK) samples will be taken predose, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h and 48 h after Rotigotine administration

• Area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg) (AUC(0-∞) norm (apparent dose))

  Pharmacokinetic (PK) samples will be taken predose, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h and 48 h after Rotigotine administration

• Area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg) (AUC(0-∞) norm (BW))

  Pharmacokinetic (PK) samples will be taken predose, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h and 48 h after Rotigotine administration

Study Arms (2)

Treatment A - Treatment B

EXPERIMENTAL

Treatment A: Test; drug product PR 2.2.1 Treatment B: Reference; drug product PR 2.1.4 Sequence of two single applications of Rotigotine transdermal patches (PR 2.2.1 first) for 24 hours separated by a Washout Period of 5 days.

Drug: Rotigotine PR 2.1.4; Drug: Rotigotine PR 2.2.1

Treatment B - Treatment A

EXPERIMENTAL

Treatment B: Reference; drug product PR 2.1.4 Treatment A: Test; drug product PR 2.2.1 Sequence of two single applications of Rotigotine transdermal patches (PR 2.1.4 first) for 24 hours separated by a Washout Period of 5 days.

Drug: Rotigotine PR 2.1.4; Drug: Rotigotine PR 2.2.1

Interventions

Rotigotine PR 2.1.4 DRUG

Treatment B: Rotigotine transdermal patch (2 mg/24 h \[10 cm\^2\]). Reference; drug product PR 2.1.4. Single application of 1 patch for 24 hours.

Also known as: Neupro

Treatment A - Treatment B; Treatment B - Treatment A

Rotigotine PR 2.2.1 DRUG

Treatment A: Rotigotine transdermal patch (2 mg/24 h \[10 cm\^2\]). Test; drug product PR 2.2.1. Single application of 1 patch for 24 hours.

Also known as: Neupro

Treatment A - Treatment B; Treatment B - Treatment A

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Japanese male and female volunteers with the age between 20 and 55 years old

You may not qualify if:

• Subject has participated or is participating in any other clinical studies of investigational drug or another Investigational Medical Product (IMP) within the last 3 months
• Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
• Subject has a QTcB (QT interval corrected for Heart Rate \[HR\] using Bazett´s formula) interval of ≥ 430 ms (≥ 450 ms for females) or any other clinically relevant finding in Electrocardiogram (ECG) at the Eligibility Assessment (EA)
• Subject is having clinically relevant allergy or clinically relevant drug hypersensitivity to any components of the Investigational Medical Product (IMP), or/and having an atopic or eczematous Dermatitis, Psoriasis and/or active skin disease
• Subject has a recent history (within 2 years) of chronic alcohol or drug abuse and has a history of significant skin hypersensitivity to transdermal products, and of an atopic or eczematous Dermatitis, Psoriasis, and/or active skin disease and have a history of suicide attempt, Epilepsy and/or seizures
• Subject has made a blood donation or a comparable blood loss within the last 3 months prior to the Eligibility Assessment (EA)
• Subject is pregnant or nursing

Sponsors & Collaborators

• UCB Pharma: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

1

Neuss, Germany

Location

MeSH Terms

Interventions

rotigotine

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 9, 2012

Record last verified: 2012-07

Locations

DE (1)