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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 two Rotigotine patches of two different formulations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotigotine PR2.2.1 first | Experimental | Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days |
|
| Rotigotine PR2.1.1 first | Experimental | Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine transdermal patch | Drug | Rotigotine 4.5 mg/10 cm^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 concentration-time curve from zero up to the last analytically quantifiable concentration. | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| Cmax of Unconjugated Rotigotine | The Cmax is the maximum plasma concentration. | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| AUC(0- ∞) of Unconjugated Rotigotine | The AUC(0- ∞) is the area under the plasma concentration-time curve from zero up to infinity | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
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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 |
|---|---|---|---|---|---|---|
| Mönchengladbach | 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. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Eight subjects that fulfilled predefined criteria for patch adhesiveness were excluded from the statistical analysis on the PKS. The predefined criteria were patch adhesiveness smaller than 75% at any timepoint or an adhesiveness lower than 90% for 12 hours or more.
A total of 50 healthy, male subjects have been randomized in order to complete the trial with at least 38 subjects qualified for the Pharmacokinetic Set (PKS). Baseline characteristics refer to the PKS which is the primary analysis set.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotigotine PR2.2.1 First | Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days |
| FG001 | Rotigotine PR2.1.1 First | Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: First Intervention- 24 Hours |
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| Period 2: Washout Period (>= 5 Days) |
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| Period 3: Second Intervention- 24 Hours |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotigotine PR2.2.1 First | Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days |
| BG001 | Rotigotine PR2.1.1 First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 concentration-time curve from zero up to the last analytically quantifiable concentration. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | ng/ mL*h | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
|
Adverse Events were collected up to 14 days after the last patch removal.
Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication.
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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 | Rotigotine PR2.2.1 | Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal 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 (UCB) |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| AUC(0-tz) Norm (Body Weight) 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). | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| AUC(0- ∞) Norm (Apparent Dose) | The AUC(0-inf) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg). | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| AUC(0- ∞) Norm (Body Weight) | The AUC(0-inf) norm (BW) is the area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg). | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine | The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg). | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| Cmax, Norm (Body Weight) of Unconjugated Rotigotine | The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg). | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| Tmax of Unconjugated Rotigotine | The tmax is the time to reach maximum plasma concentration after patch application. | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| Mean Residence Time (MRT) of Unconjugated Rotigotine | The MRT is the mean residence time. | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| Rate Constant of Elimination (λz) of Unconjugated Rotigotine | The λz of unconjugated rotigotine is the rate constant of elimination. | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| Terminal Half-Life (t1/2) of Unconjugated Rotigotine | the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz. | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine | The CL/f of unconjugated rotigotine is the apparent total body clearance. | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
| Apparent Dose | Apparent dose of unconjugated rotigotine in mg. The apparent dose was calculated by subtraction of the determined residual content of each rotigotine patch from the nominal content of rotigotine in the patch. | 24 hours |
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Height | Mean | Standard Deviation | meter (m) |
|
| Weight | Mean | Standard Deviation | kilogramm (kg) |
|
|
|
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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 | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
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|
|
|
| Primary | 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 | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
|
|
|
|
| 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 | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
|
|
|
| Secondary | AUC(0-tz) Norm (Body Weight) 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*h*kg/ mL | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
|
|
|
| Secondary | AUC(0- ∞) Norm (Apparent Dose) | The AUC(0-inf) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg). | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | ng/ mL*h/ mg | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
|
|
|
| Secondary | AUC(0- ∞) Norm (Body Weight) | The AUC(0-inf) norm (BW) is the area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg). | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | ng*h*kg/ mL | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
|
|
|
| Secondary | Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine | The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg). | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | ng/ mL/ mg | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
|
|
|
| Secondary | Cmax, Norm (Body Weight) 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 | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
|
|
|
| Secondary | Tmax of Unconjugated Rotigotine | The tmax is the time to reach maximum plasma concentration after patch application. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | hours (h) | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
|
|
|
| Secondary | Mean Residence Time (MRT) of Unconjugated Rotigotine | The MRT is the mean residence time. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | hours (h) | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
|
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|
| Secondary | Rate Constant of Elimination (λz) of Unconjugated Rotigotine | The λz of unconjugated rotigotine is the rate constant of elimination. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | 1/ h | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
|
|
|
| Secondary | Terminal Half-Life (t1/2) of Unconjugated Rotigotine | the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | hours (h) | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
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| Secondary | Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine | The CL/f of unconjugated rotigotine is the apparent total body clearance. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | L/ h | 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h |
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| Secondary | Apparent Dose | Apparent dose of unconjugated rotigotine in mg. The apparent dose was calculated by subtraction of the determined residual content of each rotigotine patch from the nominal content of rotigotine in the patch. | Pharmacokinetic Set (PKS) | Posted | Mean | Standard Deviation | mg | 24 hours |
|
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| 0 |
| 49 |
| 23 |
| 49 |
| EG001 | Rotigotine PR2.1.1 | Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours | 0 | 49 | 26 | 49 |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Gingival Bleeding | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Application Site Pruritus | General disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Application Site Oedema | General disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Application Site Paraesthesia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Lipase Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
|
| Blood Amylase Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Herpes Simplex | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Dizziness Postural | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
|
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% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.
If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.