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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565018
• Other study ID #: PD0002
• Secondary ID: 2011-004851-38
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2012
• Last updated: July 5, 2012
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Rotigotine PR 2.1.4
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.
• Rotigotine PR 2.2.1
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.

Locations

Country	Name	City	State
Germany	1	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
UCB Pharma	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Area under the plasma concentration-time curve from zero up to infinity (AUC(0-8))	The area under the curve extrapolated to infinity is calculated as the sum of AUC(0-t) and a residual part extrapolated to infinite time.	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	No
Secondary	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	No
Secondary	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	No
Secondary	Area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg) (AUC(0-8) 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	No
Secondary	Area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg) (AUC(0-8) 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	No
Secondary	Maximum plasma concentration normalized by apparent dose (Cmax,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	No
Secondary	Maximum plasma concentration normalized by body weight (Cmax,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	No
Secondary	Time to reach a maximum plasma concentration of unconjugated Rotigotine after patch application (tmax)		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	No
Secondary	Mean residence time (MRT)		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	No
Secondary	Rate constant of elimination (?z)		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	No
Secondary	Terminal half-life (t1/2)		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	No
Secondary	Relative bioavailability calculated based on maximum plasma concentration (fCmax)		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	No
Secondary	Relative bioavailability calculated based on the area under the plasma concentration-time curve (fAUC)		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	No
Secondary	Apparent total body clearance (CL/f)		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	No