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To investigate the repeated dose 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 Japanese subjects | Experimental | Repeated-Dose application of 1,2, and 4 mg / 24 hours Rotigotine in healthy Japanese subjects; Transdermal patch over 24 hours |
|
| Rotigotine in Caucasian subjects | Experimental | Multiple-Dose application of 1, 2, and 4 mg / 24 hours Rotigotine in healthy Caucasian subjects; Transdermal patch over 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine transdermal patch 1mg / 24 hours | Drug | Rotigotine transdermal patch, repeated dose application over 24 hours; 1 mg / 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval (AUCtau,ss) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours | |
| Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours | |
| Maximum concentration of unconjugated Rotigotine in plasma at steady-state (Cmax,ss) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours | |
| Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours | |
| Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours | |
| Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours | |
| Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval (AUCtau,ss) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal half-life (t1/2) of unconjugated Rotigotine in steady-state | Blood sampling at 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours | |
| Time of maximum concentration (tmax) of unconjugated Rotigotine in steady-state (tmax,ss) |
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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 |
|---|---|---|---|---|---|---|
| 1 | Neuss | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25773763 | Derived | Cawello W, Kim SR, Braun M, Elshoff JP, Masahiro T, Ikeda J, Funaki T. Pharmacokinetics, safety, and tolerability of rotigotine transdermal system in healthy Japanese and Caucasian subjects following multiple-dose administration. Eur J Drug Metab Pharmacokinet. 2016 Aug;41(4):353-62. doi: 10.1007/s13318-015-0273-6. Epub 2015 Mar 13. |
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|
| Rotigotine transdermal patch 2 mg / 24 hours | Drug | Rotigotine transdermal patch, repeated dose application over 24 hours; 2 mg / 24 hours |
|
|
| Rotigotine transdermal patch 4 mg / 24 hours | Drug | Rotigotine transdermal patch, repeated dose application over 24 hours; 4 mg / 24 hours |
|
|
| Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Maximum concentration of total Rotigotine in plasma at steady-state (Cmax,ss) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Maximum concentration of total Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Apparent total body clearance of unconjugated Rotigotine normalized by Body Weight (CL/f/BW) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Apparent volume of distribution of unconjugated Rotigotine normalized by Body Weight (Vz/f/BW) | Blood sampling at 0 hours (predose), 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 |
| Terminal half-life (t1/2) of total Rotigotine in steady-state | Blood sampling at 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours |
| Time of maximum concentration (tmax) of total Rotigotine in steady-state (tmax,ss) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Apparent total body clearance of total Rotigotine normalized by Body Weight (CL/f/BW) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Apparent volume of distribution of total Rotigotine normalized by Body Weight (Vz/f/BW) | Blood sampling at 0 hours (predose), 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 |
| ID | Term |
|---|---|
| C047508 | rotigotine |
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