Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects

December 3, 2012 updated by: UCB Pharma

A Single-site, Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects.

This study is to characterize the Pharmacokinetics (PK) of unconjugated and total Rotigotine after single and multiple doses of Rotigotine transdermal patch, and also to investigate the safety and tolerability of Rotigotine transdermal patch in healthy Chinese subjects.

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Shanghai, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Chinese subjects
Healthy volunteers with normal body weight, female subject is willing to use a double contraceptive barrier method or an oral hormonal contraceptive during the entire study

Exclusion Criteria:

Previously participated in any Rotigotine study or participated in another clinical study for an investigational drug
History of drug or alcohol abuse within the last 2 years
Suicide attempt or suicidal ideation in the past 6 months
Transient ischemic attack or stroke within the last 12 months
Current condition of epilepsy and / or seizures
History of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
History or present condition of an atopic or eczematous dermatitis, psoriasis and / or an active skin disease
Female subject is pregnant or lactating
Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's wellbeing or ability to participate in this study
Subject has a QTcB (QT interval corrected for heart rate according to Bazett's formula) interval of ≥ 450 ms for female or ≥ 430 ms for male
Subject has a relevant hepatic dysfunction (total bilirubin > 2 mg / dL or alanine aminotransferase [ALT] or aspartate aminotransferase [AST] greater than 2 times the upper limit of the normal reference range)
Subject has tested positive for human immunodeficiency virus antibodies (HIV)-1 / 2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV-Ab)
Subject has a positive urine drug screen and / or alcohol breath test on Day 1
Subject has made a blood donation or had a comparable blood loss (> 400 mL)
Subject smokes or has done so within 6 months prior to Eligibility Assessment (EA)
Subject has a clinically relevant allergy
Subject is currently taking any medication
Female subject is currently taking an oral hormonal contraceptive
Subject has symptomatic orthostatic hypotension
Subject has a pulse rate at rest less than 45 beats per minute (bpm) or more than 100 bpm
Subject has a systolic blood pressure (SBP) lower than 100 mmHg or higher than 140 mmHg or diastolic blood pressure (DBP) higher than 90 mmHg
Subject has a current or a history of clinically relevant motor disturbance, impairment of memory, sleep disturbance or neurodegenerative disease
Subject has consumed more than 3 cups (more than 450 ml) of caffeinated beverages per day
Subject's abdomen is thickly covered with hair resulting in difficulties in finding appropriate patch application sites

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotigotine, Period 1 In Period 1 (Day 1 to Day 3) all 24 subjects will receive only 1 dose 2 mg / 24 hours.	Drug: Rotigotine, Period 1 Formulation: transdermal Dosage: 2 mg / 24 hours once at Day 2 Frequency: once every 24 hours Duration: from Day 1 to Day 3 Other Names: Neupro
Experimental: Rotigotine, Period 2 In Period 2 (Day 7 to Day 14) all 24 subjects will receive 2 mg / 24 hours for 3 days then 4 mg / 24 hours for 3 days.	Drug: Rotigotine, Period 2 Formulation: transdermal Dosage: 2 mg / 24 hours for 3 days from Day 7 to Day 9, 4 mg / 24 hours for 3 days from Day 10 to Day 12 Frequency: once every 24 hours Duration: from Day 1 to Day 3 Other Names: Neupro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations of unconjugated Rotigotine for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Plasma concentrations of unconjugated Rotigotine for multiple-dose application (Period 2) Time Frame: Period 2; Day 7 to Day 14 of study	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12	Period 2; Day 7 to Day 14 of study
Plasma concentrations of total Rotigotine for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Plasma concentrations of total Rotigotine for multiple-dose application (Period 2) Time Frame: Period 2; Day 7 to Day 14 of study	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12	Period 2; Day 7 to Day 14 of study
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration (AUC 0-tz) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Maximum plasma concentration (Cmax) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero to 24 hours at steady state (AUC(0-24h),ss) for multiple-dose application (Period 2) Time Frame: Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12	Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure
Maximum plasma concentration at steady state (Cmax,ss) for multiple-dose application (Period 2) Time Frame: Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12	Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Neupro, Pharmacokinetics, healthy Chinese subjects

Additional Relevant MeSH Terms

Other Study ID Numbers

SP0913

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Measure Description	Time Frame
Terminal half-life (t½) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Time to reach a maximum plasma concentration (tmax) for single-dose application (Period 1) Time Frame: Period 1; Day1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day1 to Day 3 of study
Lag time until first concentration ≥ limit of quantitation (LOQ) (tlag) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Maximum plasma concentration normalized by Body Weight (kg) (Cmax, norm (BW)) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Maximum plasma concentration normalized by apparent dose (mg)(Cmax, norm (apparent dose)) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Maximum plasma concentration normalized by drug content of patch (mg) (Cmax, norm (mgdc)) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg) (AUC(0-tz), norm (BW)) for single-dose application (Period 1) Time Frame: Perion 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Perion 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg) (AUC(0-tz), norm (apparent dose)) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by drug content of patch (mg) (AUC(0-tz), norm (mgdc)) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to infinity (AUC(0-∞)) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg) (AUC(0-∞), norm (apparent dose)) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg) (AUC(0-∞), norm (BW)) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to infinity normalized by drug content of patch (mg) (AUC(0-∞), norm (mgdc)) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Apparent total body clearance (CL/F) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Apparent total body clearance normalized by body weight (kg) (CL/F norm (BW)) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Apparent volume of distribution (Vz/f) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Apparent volume of distribution normalized by body weight (kg) (Vz/f norm (BW)) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Mean residence time (MRT) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Rate constant of elimination (ke) for single-dose application (Period 1) Time Frame: Period 1; Day 1 to Day 3 of study	Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1	Period 1; Day 1 to Day 3 of study
Terminal half-life (t½) for multiple-dose application Time Frame: Period 2; Day 7 to Day 14 of study	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12	Period 2; Day 7 to Day 14 of study
Time to reach a maximum plasma concentration at steady state (tmax,ss) for multiple-dose application (Period 2) Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure.	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12	Period 2; Day 9 to Day 12 of study for this Outcome Measure.
Maximum plasma concentration at steady state normalized by body weight (kg) (Cmax,ss,norm(BW)) for multiple-dose application (Period 2) Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure.	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12	Period 2; Day 9 to Day 12 of study for this Outcome Measure.
Maximum plasma concentration at steady state normalized by apparent dose (mg) (Cmax, ss, norm (apparent dose)) for multiple-dose application (Period 2) Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure.	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12	Period 2; Day 9 to Day 12 of study for this Outcome Measure.
Maximum plasma concentration at steady state normalized by drug content of patch (mg) (Cmax, ss, norm (mgdc)) for multiple-dose application (Period 2) Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12	Period 2; Day 9 to Day 12 of study for this Outcome Measure
Minimum plasma concentration at steady state (Cmin, ss) for multiple-dose application (Period 2) Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12	Period 2; Day 9 to Day 12 of study for this Outcome Measure
Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by body weight (kg) (AUC(0-24h), ss, norm (BW)) for multiple-dose application (Period 2) Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12	Period 2; Day 9 to Day 12 of study for this Outcome Measure
Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by apparent dose (mg) (AUC(0-24), ss, norm (apparent dose)) for multiple-dose application (Period 2) Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12	Period 2; Day 9 to Day 12 of study for this Outcome Measure
Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by drug content of patch (mg) (AUC(0-24), ss, norm (mgdc)) for multiple-dose application (Period 2) Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12	Period 2; Day 9 to Day 12 of study for this Outcome Measure
Apparent total body clearance (CL/F) for multiple-dose application (Period 2) Time Frame: Period 2; Day 7 to Day 14 of study	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.	Period 2; Day 7 to Day 14 of study
Apparent total body clearance normalized by body weight (kg) (CL/F norm (BW)) for multiple-dose application (Period 2) Time Frame: Period 2; Day 7 to Day 14 of study	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.	Period 2; Day 7 to Day 14 of study
Apparent volume of distribution (Vz/f) for multiple-dose application (Period 2) Time Frame: Period 2; Day 7 to Day 14 of study	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.	Period 2; Day 7 to Day 14 of study
Apparent volume of distribution normalized by body weight (kg) (Vz/f norm (BW)) for multiple-dose application (Period 2) Time Frame: Period 2; Day 7 to Day 14 of study	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.	Period 2; Day 7 to Day 14 of study
Mean residence time (MRT) for multiple-dose application (Period 2) Time Frame: Period 2; Day 7 to Day 14 of study	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.	Period 2; Day 7 to Day 14 of study
Rate constant of elimination (ke) for multiple-dose application (Period 2) Time Frame: Period 2; Day 7 to Day 14 of study	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.	Period 2; Day 7 to Day 14 of study
Peak to trough fluctuation (PTF) for multiple-dose application (Period 2) Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure	Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12.	Period 2; Day 9 to Day 12 of study for this Outcome Measure

Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects

A Single-site, Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects.

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on Rotigotine, Period 1

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Drug Interventions

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CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations