Parallel Group Trial to Evaluate the Pharmacokinetics and Safety / Tolerability of Single-Dose Treatment With Rotigotine Continuous Delivery System (10 cm2 / 4.5 mg) in Japanese and Caucasian Healthy Subjects
Sponsor study identifier
interventional
50
1 country
1
Study Start
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2002
Actual (reported)Study Completion
December 2002
Actual (reported)To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian Female and Male Healthy Subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2002
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
October 2002
Actual (reported)December 2002
Actual (reported)January 3, 2013
Actual (reported)January 4, 2013
Actual (reported)Area under the concentration-time curve (AUC) from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of unconjugated Rotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized [AUC (0-t)norm] of unconjugated Rotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of unconjugated Rotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Terminal half-life [t1/2] of unconjugated Rotigotine
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Time of maximum concentration [tmax] of unconjugated Rotigotine
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of unconjugated Rotigotine
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Total body clearance (CL) of unconjugated Rotigotine normalized by body weight (BW) [CL/f/BW]
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Apparent volume of distribution of unconjugated Rotigotine normalized by body weight [Vz/f/BW]
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
* Rotigotine transdermal patch * Single dose application of 2 mg / 24 hours Rotigotine in Healthy Japanese subjects * Transdermal patch over 24 hours
* Rotigotine transdermal patch * Single-Dose application of 2 mg / 24 hours Rotigotine in healthy Caucasian subjects * Transdermal patch over 24 hours
Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)
01
Neuss, Germany
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
50 participants (actual enrollment reported by the registry).
First Submitted
January 3, 2013
First Posted
January 4, 2013
Study Start
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
Medroxyprogesterone Acetate Injection 150 mg/1 mL in Postmenopausal Women
Maximum concentration in plasma normalized by body weight [Cmax,norm] of unconjugated Rotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Rotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of total Rotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Rotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Despropylrotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized by body weight [AUC (0-t)] of total Despropylrotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of total Despropylrotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Despropylrotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Desthienylethylrotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized by body weight [AUC (0-t)] of total Desthienylethylrotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of total Desthienylethylrotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma normalized by body weight [Cmax, norm] of total Desthienylethylrotigotine
Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose
From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Contact the study team to confirm eligibility.
Primary Completion
October 2002
Actual (reported)Study Completion
December 2002
Actual (reported)Last Updated
October 20, 2014
Record last verified: 2013-01
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