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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01675024
First received: August 27, 2012
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Rotigotine, Period 1
Drug: Rotigotine, Period 2
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-site, Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Plasma concentrations of unconjugated Rotigotine for single-dose application (Period 1) [ Time Frame: Period 1; Day 1 to Day 3 of study ] [ Designated as safety issue: No ]
    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

  • Plasma concentrations of unconjugated Rotigotine for multiple-dose application (Period 2) [ Time Frame: Period 2; Day 7 to Day 14 of study ] [ Designated as safety issue: No ]
    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

  • Plasma concentrations of total Rotigotine for single-dose application (Period 1) [ Time Frame: Period 1; Day 1 to Day 3 of study ] [ Designated as safety issue: No ]
    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

  • Plasma concentrations of total Rotigotine for multiple-dose application (Period 2) [ Time Frame: Period 2; Day 7 to Day 14 of study ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • Maximum plasma concentration (Cmax) for single-dose application (Period 1) [ Time Frame: Period 1; Day 1 to Day 3 of study ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Terminal half-life (t½) for single-dose application (Period 1) [ Time Frame: Period 1; Day 1 to Day 3 of study ] [ Designated as safety issue: No ]
    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

  • Time to reach a maximum plasma concentration (tmax) for single-dose application (Period 1) [ Time Frame: Period 1; Day1 to Day 3 of study ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • Apparent total body clearance (CL/F) for single-dose application (Period 1) [ Time Frame: Period 1; Day 1 to Day 3 of study ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • Apparent volume of distribution (Vz/f) for single-dose application (Period 1) [ Time Frame: Period 1; Day 1 to Day 3 of study ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • Mean residence time (MRT) for single-dose application (Period 1) [ Time Frame: Period 1; Day 1 to Day 3 of study ] [ Designated as safety issue: No ]
    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

  • Rate constant of elimination (ke) for single-dose application (Period 1) [ Time Frame: Period 1; Day 1 to Day 3 of study ] [ Designated as safety issue: No ]
    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

  • Terminal half-life (t½) for multiple-dose application [ Time Frame: Period 2; Day 7 to Day 14 of study ] [ Designated as safety issue: No ]
    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

  • 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. ] [ Designated as safety issue: No ]
    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

  • 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. ] [ Designated as safety issue: No ]
    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

  • 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. ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • Apparent total body clearance (CL/F) for multiple-dose application (Period 2) [ Time Frame: Period 2; Day 7 to Day 14 of study ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Apparent volume of distribution (Vz/f) for multiple-dose application (Period 2) [ Time Frame: Period 2; Day 7 to Day 14 of study ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Mean residence time (MRT) for multiple-dose application (Period 2) [ Time Frame: Period 2; Day 7 to Day 14 of study ] [ Designated as safety issue: No ]
    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.

  • Rate constant of elimination (ke) for multiple-dose application (Period 2) [ Time Frame: Period 2; Day 7 to Day 14 of study ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: August 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Neupro

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675024

Locations
China
Shanghai, China
Sponsors and Collaborators
UCB, Inc.
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01675024     History of Changes
Other Study ID Numbers: SP0913
Study First Received: August 27, 2012
Last Updated: December 3, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by UCB, Inc.:
Neupro, Pharmacokinetics, healthy Chinese subjects

Additional relevant MeSH terms:
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014