Trial · NCT01059903
Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body
NCT01059903, Phase 1, Completed, UCB Pharma; results first posted 2011-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body. Trials, record NCT01059903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01059903
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body
- NCT number
- NCT01059903
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 50 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Healthy Volunteers
- Interventions
- Rotigotine transdermal patch
- First posted
- 2010-02-01
- Last updated
- 2012-05-22
- Results first posted
- 2011-03-03
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AUC(0-tz) of Unconjugated Rotigotine | 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 | The AUC(0-tz) is the area under the concentration-time curve from zero up to the last analytically quantifiable concentration. |
| Primary | Cmax of Unconjugated Rotigotine | 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 | The Cmax is the maximum plasma concentration. |
| Primary | AUC(0- ∞) of Unconjugated Rotigotine | 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 | The AUC(0- ∞) is the area under the plasma concentration-time curve from zero up to infinity |
| Secondary | AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine | 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 | 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). |
| Secondary | AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine | 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 | 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). |
| Secondary | AUC(0- ∞) Norm (Apparent Dose) | 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 | 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). |
| Secondary | AUC(0- ∞) Norm (Body Weight) | 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 | 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). |
| Secondary | Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine | 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 | The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg). |
| Secondary | Cmax, Norm (Body Weight) of Unconjugated Rotigotine | 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 | The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg). |
| Secondary | Tmax of Unconjugated Rotigotine | 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 | The tmax is the time to reach maximum plasma concentration after patch application. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | AUC(0-tz) of Unconjugated Rotigotine | 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 | Pharmacokinetic Set (PKS) | ng/ mL*h | MEAN |
| PRIMARY | Cmax of Unconjugated Rotigotine | 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 | Pharmacokinetic Set (PKS) | ng/ mL | MEAN |
| PRIMARY | AUC(0- ∞) of Unconjugated Rotigotine | 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 | Pharmacokinetic Set (PKS) | ng/ mL*h | MEAN |
| SECONDARY | AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine | 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 | Pharmacokinetic Set (PKS) | ng/ mL*h/ mg | MEAN |
| SECONDARY | AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine | 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 | Pharmacokinetic Set (PKS) | ng*h*kg/ mL | MEAN |
| SECONDARY | AUC(0- ∞) Norm (Apparent Dose) | 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 | Pharmacokinetic Set (PKS) | ng/ mL*h/ mg | MEAN |
| SECONDARY | AUC(0- ∞) Norm (Body Weight) | 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 | Pharmacokinetic Set (PKS) | ng*h*kg/ mL | MEAN |
| SECONDARY | Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine | 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 | Pharmacokinetic Set (PKS) | ng/ mL/ mg | MEAN |
| SECONDARY | Cmax, Norm (Body Weight) of Unconjugated Rotigotine | 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 | Pharmacokinetic Set (PKS) | ng/ mL*kg | MEAN |
| SECONDARY | Tmax of Unconjugated Rotigotine | 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 | Pharmacokinetic Set (PKS) | hours (h) | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| AUC(0-tz) of Unconjugated Rotigotine | Rotigotine PR2.2.1 | 5.2704 | Standard Deviation 3.1435 | ng/ mL*h | |
| AUC(0-tz) of Unconjugated Rotigotine | Rotigotine PR2.1.1 | 5.4724 | Standard Deviation 2.4755 | ng/ mL*h | |
| Cmax of Unconjugated Rotigotine | Rotigotine PR2.2.1 | 0.26156 | Standard Deviation 0.15594 | ng/ mL | |
| Cmax of Unconjugated Rotigotine | Rotigotine PR2.1.1 | 0.25774 | Standard Deviation 0.11184 | ng/ mL | |
| AUC(0- ∞) of Unconjugated Rotigotine | Rotigotine PR2.2.1 | 5.36933 | Standard Deviation 3.17013 | ng/ mL*h | |
| AUC(0- ∞) of Unconjugated Rotigotine | Rotigotine PR2.1.1 | 5.56925 | Standard Deviation 2.49370 | ng/ mL*h | |
| AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine | Rotigotine PR2.2.1 | 2.56504 | Standard Deviation 0.88171 | ng/ mL*h/ mg | |
| AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine | Rotigotine PR2.1.1 | 2.66067 | Standard Deviation 1.02321 | ng/ mL*h/ mg | |
| AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine | Rotigotine PR2.2.1 | 412.942 | Standard Deviation 239.918 | ng*h*kg/ mL | |
| AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine | Rotigotine PR2.1.1 | 434.101 | Standard Deviation 206.274 | ng*h*kg/ mL |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: First Intervention- 24 Hours | STARTED | Rotigotine PR2.2.1 First | 25 | |
| Period 1: First Intervention- 24 Hours | STARTED | Rotigotine PR2.1.1 First | 25 | |
| Period 1: First Intervention- 24 Hours | COMPLETED | Rotigotine PR2.2.1 First | 24 | |
| Period 1: First Intervention- 24 Hours | COMPLETED | Rotigotine PR2.1.1 First | 24 | |
| Period 1: First Intervention- 24 Hours | NOT COMPLETED | Rotigotine PR2.2.1 First | 1 | |
| Period 1: First Intervention- 24 Hours | NOT COMPLETED | Rotigotine PR2.1.1 First | 1 | |
| Period 2: Washout Period (>= 5 Days) | STARTED | Rotigotine PR2.2.1 First | 24 | |
| Period 2: Washout Period (>= 5 Days) | STARTED | Rotigotine PR2.1.1 First | 24 | |
| Period 2: Washout Period (>= 5 Days) | COMPLETED | Rotigotine PR2.2.1 First | 24 | |
| Period 2: Washout Period (>= 5 Days) | COMPLETED | Rotigotine PR2.1.1 First | 24 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Rotigotine PR2.2.1 | 4 | 49 | 4 |
| other | Nausea | Gastrointestinal disorders | Rotigotine PR2.1.1 | 2 | 49 | 2 |
| other | Vomiting | Gastrointestinal disorders | Rotigotine PR2.2.1 | 2 | 49 | 2 |
| other | Vomiting | Gastrointestinal disorders | Rotigotine PR2.1.1 | 1 | 49 | 2 |
| other | Dyspepsia | Gastrointestinal disorders | Rotigotine PR2.2.1 | 2 | 49 | 2 |
| other | Dyspepsia | Gastrointestinal disorders | Rotigotine PR2.1.1 | 0 | 49 | |
| other | Constipation | Gastrointestinal disorders | Rotigotine PR2.2.1 | 0 | 49 | |
| other | Constipation | Gastrointestinal disorders | Rotigotine PR2.1.1 | 1 | 49 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Rotigotine PR2.2.1 | 0 | 49 | |
| other | Abdominal Pain | Gastrointestinal disorders | Rotigotine PR2.1.1 | 1 | 49 | 1 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rotigotine PR2.2.1 | ||
| Total, all-cause mortality | Rotigotine PR2.1.1 | ||
| Total, other adverse events | Rotigotine PR2.2.1 | 23 | 49 |
| Total, other adverse events | Rotigotine PR2.1.1 | 26 | 49 |
| Total, serious adverse events | Rotigotine PR2.2.1 | 0 | 49 |
| Total, serious adverse events | Rotigotine PR2.1.1 | 0 | 49 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24006953 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rotigotine PR2.2.1 vs Rotigotine PR2.1.1: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01059903
GET https://conductscience.org/api/trials/v1/NCT01059903/results?page=2