Trial · NCT00881894
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
NCT00881894, Phase 1, Completed, UCB Pharma; results first posted 2009-12-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body. Trials, record NCT00881894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00881894
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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 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
- NCT number
- NCT00881894
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 52 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Healthy
- Interventions
- Rotigotine transdermal patch
- First posted
- 2009-04-15
- Last updated
- 2014-10-27
- Results first posted
- 2009-12-25
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AUC(0-tz) of Unconjugated Rotigotine | 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 | The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration. |
| Primary | Cmax of Unconjugated Rotigotine | 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. | The Cmax is the maximum plasma concentration. |
| Secondary | AUC(0-∞) of Unconjugated Rotigotine | 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. | 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 | 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. | 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 (BW) of Unconjugated Rotigotine | 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. | 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 | Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine | 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. | The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose. |
| Secondary | Cmax,Norm (BW) of Unconjugated Rotigotine | 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. | The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg). |
| Secondary | Tmax of Unconjugated Rotigotine | 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. | The Tmax is the time to reach a maximum plasma concentration after patch application. |
| Secondary | MRT of Unconjugated Rotigotine | 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. | The MRT is the mean residence time. |
| Secondary | λz of Unconjugated Rotigotine | 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. | The λz is the rate constant of elimination. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 | 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 | Pharmacokinetic Set (PKS) | (ng/ mL)*h | MEAN |
| PRIMARY | Cmax of Unconjugated Rotigotine | 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. | Pharmacokinetic Set (PKS) | ng/ mL | MEAN |
| SECONDARY | AUC(0-∞) of Unconjugated Rotigotine | 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. | Pharmacokinetic Set (PKS) | (ng/ mL)*h | MEAN |
| SECONDARY | AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine | 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. | Pharmacokinetic Set (PKS) | (ng/ mL)*(h/ mg) | MEAN |
| SECONDARY | AUC(0-tz)Norm (BW) of Unconjugated Rotigotine | 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. | Pharmacokinetic Set (PKS) | (ng/ mL)*h*kg | MEAN |
| SECONDARY | Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine | 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. | Pharmacokinetic Set (PKS) | (ng/ mL) / mg | MEAN |
| SECONDARY | Cmax,Norm (BW) of Unconjugated Rotigotine | 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. | Pharmacokinetic Set (PKS) | (ng/ mL)*kg | MEAN |
| SECONDARY | Tmax of Unconjugated Rotigotine | 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. | Pharmacokinetic Set (PKS) | hour (h) | MEDIAN |
| SECONDARY | MRT of Unconjugated Rotigotine | 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. | Pharmacokinetic Set (PKS) | hour (h) | MEAN |
| SECONDARY | λz of Unconjugated Rotigotine | 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. | Pharmacokinetic Set (PKS) | 1/ hour (1/h) | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
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 | Treatment A (Test: PR2.1.1) | 3.0168 | Standard Deviation 1.4077 | (ng/ mL)*h | |
| AUC(0-tz) of Unconjugated Rotigotine | Treatment B (Reference: PR1.0) | 3.0635 | Standard Deviation 1.4309 | (ng/ mL)*h | |
| Cmax of Unconjugated Rotigotine | Treatment A (Test: PR2.1.1) | 0.14418 | Standard Deviation 0.06211 | ng/ mL | |
| Cmax of Unconjugated Rotigotine | Treatment B (Reference: PR1.0) | 0.15155 | Standard Deviation 0.06540 | ng/ mL | |
| AUC(0-∞) of Unconjugated Rotigotine | Treatment A (Test: PR2.1.1) | 3.12622 | Standard Deviation 1.41536 | (ng/ mL)*h | |
| AUC(0-∞) of Unconjugated Rotigotine | Treatment B (Reference: PR1.0) | 3.16403 | Standard Deviation 1.43028 | (ng/ mL)*h | |
| AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine | Treatment A (Test: PR2.1.1) | 1.78200 | Standard Deviation 0.71912 | (ng/ mL)*(h/ mg) | |
| AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine | Treatment B (Reference: PR1.0) | 1.58900 | Standard Deviation 0.54806 | (ng/ mL)*(h/ mg) | |
| AUC(0-tz)Norm (BW) of Unconjugated Rotigotine | Treatment A (Test: PR2.1.1) | 239.241 | Standard Deviation 112.475 | (ng/ mL)*h*kg | |
| AUC(0-tz)Norm (BW) of Unconjugated Rotigotine | Treatment B (Reference: PR1.0) | 243.841 | Standard Deviation 116.640 | (ng/ mL)*h*kg |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence A-B (Test: PR2.1.1 - Reference: PR1.0) | 26 | |
| Overall Study | STARTED | Sequence B-A (Reference: PR1.0 - Test: PR2.1.1) | 26 | |
| Overall Study | Pharmacokinetic Set (PKS) | Sequence A-B (Test: PR2.1.1 - Reference: PR1.0) | 23 | |
| Overall Study | Pharmacokinetic Set (PKS) | Sequence B-A (Reference: PR1.0 - Test: PR2.1.1) | 21 | |
| Overall Study | COMPLETED | Sequence A-B (Test: PR2.1.1 - Reference: PR1.0) | 25 | |
| Overall Study | COMPLETED | Sequence B-A (Reference: PR1.0 - Test: PR2.1.1) | 23 | |
| Overall Study | NOT COMPLETED | Sequence A-B (Test: PR2.1.1 - Reference: PR1.0) | 1 | |
| Overall Study | NOT COMPLETED | Sequence B-A (Reference: PR1.0 - Test: PR2.1.1) | 3 |
Source ClinicalTrials.gov
Adverse events28
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 | Abnormal Sensation in Eye | Eye disorders | Treatment A (Test: PR2.1.1) | 1 | 51 | 1 |
| other | Abnormal Sensation in Eye | Eye disorders | Treatment B (Reference: PR1.0) | 1 | 51 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment A (Test: PR2.1.1) | 4 | 51 | 4 |
| other | Nausea | Gastrointestinal disorders | Treatment B (Reference: PR1.0) | 3 | 51 | 3 |
| other | Vomiting | Gastrointestinal disorders | Treatment A (Test: PR2.1.1) | 2 | 51 | 2 |
| other | Vomiting | Gastrointestinal disorders | Treatment B (Reference: PR1.0) | 1 | 51 | 1 |
| other | Application Site Pruritus | General disorders | Treatment A (Test: PR2.1.1) | 12 | 51 | 12 |
| other | Application Site Pruritus | General disorders | Treatment B (Reference: PR1.0) | 12 | 51 | 12 |
| other | Application Site Cold Feeling | General disorders | Treatment A (Test: PR2.1.1) | 1 | 51 | 1 |
| other | Application Site Cold Feeling | General disorders | Treatment B (Reference: PR1.0) | 0 | 51 | 0 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment A (Test: PR2.1.1) | ||
| Total, all-cause mortality | Treatment B (Reference: PR1.0) | ||
| Total, other adverse events | Treatment A (Test: PR2.1.1) | 21 | 51 |
| Total, other adverse events | Treatment B (Reference: PR1.0) | 21 | 51 |
| Total, serious adverse events | Treatment A (Test: PR2.1.1) | 0 | 51 |
| Total, serious adverse events | Treatment B (Reference: PR1.0) | 0 | 51 |
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 |
|---|
| Treatment A (Test: PR2.1.1) vs Treatment B (Reference: PR1.0): 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/NCT00881894
GET https://conductscience.org/api/trials/v1/NCT00881894/results?page=2