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The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing processes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A-B (Test: PR2.1.1 - Reference: PR1.0) | Experimental | Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days |
|
| Sequence B-A (Reference: PR1.0 - Test: PR2.1.1) | Experimental | Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine transdermal patch | Drug | Rotigotine 4.5mg/10cm^2 patch applied for 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-tz) of Unconjugated Rotigotine | The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration. | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application |
| Cmax of Unconjugated Rotigotine | The Cmax is the maximum plasma concentration. | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-∞) of Unconjugated Rotigotine | The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity. | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
| AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine |
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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 |
|---|---|---|---|---|---|---|
| Neuss | North Rhine-Westphalia | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24006953 | Derived | Elshoff JP, Timmermann L, Schmid M, Arth C, Komenda M, Brunnert M, Bauer L. Comparison of the bioavailability and adhesiveness of different rotigotine transdermal patch formulations. Curr Med Res Opin. 2013 Dec;29(12):1657-62. doi: 10.1185/03007995.2013.841666. Epub 2013 Sep 23. |
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Patients with an insufficient patch adhesiveness were excluded from the PKS.
A total of 52, healthy, male subjects has been randomized in order to complete the trial with at least 44 subjects eligible for the Pharmacokinetic Set (PKS). Baseline characteristics refer to the PKS.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A-B (Test: PR2.1.1 - Reference: PR1.0) | Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days |
| FG001 | Sequence B-A (Reference: PR1.0 - Test: PR2.1.1) | Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence A-B (Test: PR2.1.1 - Reference: PR1.0) | Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days |
| BG001 | Sequence B-A (Reference: PR1.0 - Test: PR2.1.1) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC(0-tz) of Unconjugated Rotigotine | The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | (ng/ mL)*h | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application |
|
Adverse Events (AEs) were collected within 48 hours.
Adverse events are reported for the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of trial medication (N=52). Two subjects terminated the study prematurely after period 1 (1 subject in sequence A-B and 1 in sequence B-A). Therefore the number of subject exposed to each treatment is N=51.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A (Test: PR2.1.1) | Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Sensation in Eye | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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The AUC(0-tz)Norm (Apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg). |
| Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
| AUC(0-tz)Norm (BW) of Unconjugated Rotigotine | The AUC(0-tz)Norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg). | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
| Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine | The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose. | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
| Cmax,Norm (BW) of Unconjugated Rotigotine | The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg). | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
| Tmax of Unconjugated Rotigotine | The Tmax is the time to reach a maximum plasma concentration after patch application. | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
| MRT of Unconjugated Rotigotine | The MRT is the mean residence time. | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24(before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
| λz of Unconjugated Rotigotine | The λz is the rate constant of elimination. | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
| t1/2 of Unconjugated Rotigotine | The t1/2 is the terminal half- life. | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
| CL/f of Unconjugated Rotigotine | The CL/f is the apparent total body clearance. | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
| Apparent Dose | Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2. | 48 hours |
Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
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Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
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| Primary | Cmax of Unconjugated Rotigotine | The Cmax is the maximum plasma concentration. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | ng/ mL | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
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| Secondary | AUC(0-∞) of Unconjugated Rotigotine | The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | (ng/ mL)*h | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
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| Secondary | AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine | The AUC(0-tz)Norm (Apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg). | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | (ng/ mL)*(h/ mg) | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
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| Secondary | AUC(0-tz)Norm (BW) of Unconjugated Rotigotine | The AUC(0-tz)Norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg). | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | (ng/ mL)*h*kg | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
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| Secondary | Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine | The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | (ng/ mL) / mg | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
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| Secondary | Cmax,Norm (BW) of Unconjugated Rotigotine | The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg). | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | (ng/ mL)*kg | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
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| Secondary | Tmax of Unconjugated Rotigotine | The Tmax is the time to reach a maximum plasma concentration after patch application. | Pharmacokinetic Set (PKS) | Posted | Median | Full Range | hour (h) | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
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| Secondary | MRT of Unconjugated Rotigotine | The MRT is the mean residence time. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | hour (h) | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24(before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
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| Secondary | λz of Unconjugated Rotigotine | The λz is the rate constant of elimination. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | 1/ hour (1/h) | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
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| Secondary | t1/2 of Unconjugated Rotigotine | The t1/2 is the terminal half- life. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | hour (h) | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
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| Secondary | CL/f of Unconjugated Rotigotine | The CL/f is the apparent total body clearance. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | L/ h | Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application. |
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| Secondary | Apparent Dose | Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | mg | 48 hours |
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| 0 |
| 51 |
| 21 |
| 51 |
| EG001 | Treatment B (Reference: PR1.0) | Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours | 0 | 51 | 21 | 51 |
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Application Site Pruritus | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Application Site Cold Feeling | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Syncope Vasovagal | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Disturbance in Attention | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.