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| Name | Class |
|---|---|
| Schwarz BioSciences GmbH | UNKNOWN |
| Alfred-Nobel-Str. 10 | UNKNOWN |
| 40789 Monheim am Rhein | UNKNOWN |
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To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian Female and Male Healthy Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotigotine in Healthy Japanese | Experimental |
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| Rotigotine in Caucasian | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine transdermal patch | Drug | Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal half-life [t1/2] 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 01 | Neuss | Germany |
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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 |
| Time of maximum concentration [tmax] 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 to infinity [AUC (0-inf)] 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 |
| Total body clearance (CL) of unconjugated Rotigotine normalized by body weight (BW) [CL/f/BW] | 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 |
| Apparent volume of distribution of unconjugated Rotigotine normalized by body weight [Vz/f/BW] | 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 |
| Amounts of unconjugated Rotigotine excreted in urine [Ae] | 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 |
| Fraction of unconjugated Rotigotine excreted into urine [fe (% of dose)] | 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 |
| Renal Clearance [CLR] 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 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 |
| Time of maximum concentration [tmax] 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 to infinity [AUC (0-inf)] 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 |
| Total body clearance of total Rotigotine normalized by body weight [CL/f/BW] | 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 |
| Apparent volume of distribution normalized of total Rotigotine by body weight [Vz/f/BW] | 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 |
| Amount of total Rotigotine excreted into urine [Ae] | 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 |
| Fraction of total Rotigotine excreted into urine [fe (% of dose)] | 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 |
| Renal clearance [CLR] 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 |
| Terminal half-life [t1/2] 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 |
| Time of maximum concentration [tmax] 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 to infinity [AUC (0-inf)] 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 |
| Total body clearance of total Despropylrotigotine normalized by body weight [CL/f/BW] | 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 |
| Apparent volume of distribution of total Despropylrotigotine normalized by body weight [Vz/f/BW] | 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 |
| Amount of total Despropylrotigotine excreted into urine [Ae] | 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 |
| Fraction of total Despropylrotigotine excreted into urine [fe (% of dose)] | 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 |
| Renal Clearance [CLR] 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 |
| Terminal half-life [t1/2] 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 |
| Time of maximum concentration [tmax] 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 to infinity [AUC (0-inf)] 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 |
| Total body clearance of total Desthienylethylrotigotine normalized by body weight [CL/f/BW] | 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 |
| Apparent volume of distribution of total Desthienylethylrotigotine normalized by body weight [Vz/f/BW] | 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 |
| Amount of total Desthienylethylrotigotine excreted into urine [Ae] | 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 |
| Fraction of total Desthienylethylrotigotine excreted into urine [fe (%of dose)] | 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 |
| Renal clearance [CLR] 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 |
| ID | Term |
|---|---|
| C047508 | rotigotine |
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