Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT00881894
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2009-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C047508', 'term': 'rotigotine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493', 'title': 'UCB Clinical Trial Call Center', 'organization': 'UCB'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected within 48 hours.', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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', 'otherNumAtRisk': 51, 'otherNumAffected': 21, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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', 'otherNumAtRisk': 51, 'otherNumAffected': 21, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abnormal Sensation in Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Application Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Application Site Cold Feeling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Syncope Vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Disturbance in Attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC(0-tz) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0168', 'spread': '1.4077', 'groupId': 'OG000'}, {'value': '3.0635', 'spread': '1.4309', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of geometric LS- Means', 'ciPctValue': '90', 'paramValue': '0.9864', 'ciLowerLimit': '0.9103', 'ciUpperLimit': '1.0688', 'estimateComment': 'Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.', 'groupDescription': 'Bioequivalence testing by using the 90% Confidence Interval (CI).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.'}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': 'The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.', 'unitOfMeasure': '(ng/ mL)*h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'PRIMARY', 'title': 'Cmax of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14418', 'spread': '0.06211', 'groupId': 'OG000'}, {'value': '0.15155', 'spread': '0.06540', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of geometric LS- Means', 'ciPctValue': '90', 'paramValue': '0.9584', 'ciLowerLimit': '0.8861', 'ciUpperLimit': '1.0367', 'estimateComment': 'Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.', 'groupDescription': 'Bioequivalence testing by using the 90% Confidence Interval (CI).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': 'The Cmax is the maximum plasma concentration.', 'unitOfMeasure': 'ng/ mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'AUC(0-∞) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '3.12622', 'spread': '1.41536', 'groupId': 'OG000'}, {'value': '3.16403', 'spread': '1.43028', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of geometric LS- Means', 'ciPctValue': '90', 'paramValue': '0.9896', 'ciLowerLimit': '0.9179', 'ciUpperLimit': '1.0671', 'groupDescription': 'Bioequivalence testing by using the 90% Confidence Interval (CI).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': 'The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity.', 'unitOfMeasure': '(ng/ mL)*h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '1.78200', 'spread': '0.71912', 'groupId': 'OG000'}, {'value': '1.58900', 'spread': '0.54806', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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).', 'unitOfMeasure': '(ng/ mL)*(h/ mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'AUC(0-tz)Norm (BW) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '239.241', 'spread': '112.475', 'groupId': 'OG000'}, {'value': '243.841', 'spread': '116.640', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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).', 'unitOfMeasure': '(ng/ mL)*h*kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '0.085822', 'spread': '0.032789', 'groupId': 'OG000'}, {'value': '0.079619', 'spread': '0.027178', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': 'The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose.', 'unitOfMeasure': '(ng/ mL) / mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'Cmax,Norm (BW) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4391', 'spread': '4.9667', 'groupId': 'OG000'}, {'value': '12.0441', 'spread': '5.3133', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': 'The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg).', 'unitOfMeasure': '(ng/ mL)*kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'Tmax of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '16.00', 'spread': '6.18', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '28.0'}, {'value': '16.00', 'spread': '5.26', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '26.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '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.', 'description': 'The Tmax is the time to reach a maximum plasma concentration after patch application.', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'MRT of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '19.012', 'spread': '1.809', 'groupId': 'OG000'}, {'value': '18.882', 'spread': '1.802', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': 'The MRT is the mean residence time.', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'λz of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '0.153848', 'spread': '0.037525', 'groupId': 'OG000'}, {'value': '0.151239', 'spread': '0.025301', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': 'The λz is the rate constant of elimination.', 'unitOfMeasure': '1/ hour (1/h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 't1/2 of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7665', 'spread': '1.1499', 'groupId': 'OG000'}, {'value': '4.7128', 'spread': '0.8088', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': 'The t1/2 is the terminal half- life.', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'CL/f of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '1825.38', 'spread': '1058.21', 'groupId': 'OG000'}, {'value': '1822.13', 'spread': '1060.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': 'The CL/f is the apparent total body clearance.', 'unitOfMeasure': 'L/ h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'Apparent Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Test: PR2.1.1)', 'description': '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'}, {'id': 'OG001', 'title': 'Treatment B (Reference: PR1.0)', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '1.676', 'spread': '0.423', 'groupId': 'OG000'}, {'value': '1.890', 'spread': '0.561', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)', 'description': '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'}, {'id': 'FG001', 'title': 'Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)', 'description': '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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Pharmacokinetic Set (PKS)', 'achievements': [{'comment': 'Patients with an insufficient patch adhesiveness were excluded from the PKS.', 'groupId': 'FG000', 'numSubjects': '23'}, {'comment': 'Patients with an insufficient patch adhesiveness were excluded from the PKS.', 'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Consent withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other reasons for premature termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'Patients with an insufficient patch adhesiveness were excluded from the PKS.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)', 'description': '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'}, {'id': 'BG001', 'title': 'Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)', 'description': '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'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '39.0', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.98', 'spread': '7.08', 'groupId': 'BG000'}, {'value': '79.98', 'spread': '8.20', 'groupId': 'BG001'}, {'value': '79.45', 'spread': '7.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-17', 'studyFirstSubmitDate': '2009-04-13', 'resultsFirstSubmitDate': '2009-11-20', 'studyFirstSubmitQcDate': '2009-04-14', 'lastUpdatePostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-11-20', 'studyFirstPostDateStruct': {'date': '2009-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(0-tz) of Unconjugated Rotigotine', 'timeFrame': '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', 'description': 'The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.'}, {'measure': 'Cmax of Unconjugated Rotigotine', 'timeFrame': '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.', 'description': 'The Cmax is the maximum plasma concentration.'}], 'secondaryOutcomes': [{'measure': 'AUC(0-∞) of Unconjugated Rotigotine', 'timeFrame': '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.', 'description': 'The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity.'}, {'measure': 'AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine', 'timeFrame': '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.', 'description': '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).'}, {'measure': 'AUC(0-tz)Norm (BW) of Unconjugated Rotigotine', 'timeFrame': '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.', 'description': '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).'}, {'measure': 'Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine', 'timeFrame': '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.', 'description': 'The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose.'}, {'measure': 'Cmax,Norm (BW) of Unconjugated Rotigotine', 'timeFrame': '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.', 'description': 'The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg).'}, {'measure': 'Tmax of Unconjugated Rotigotine', 'timeFrame': '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.', 'description': 'The Tmax is the time to reach a maximum plasma concentration after patch application.'}, {'measure': 'MRT of Unconjugated Rotigotine', 'timeFrame': '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.', 'description': 'The MRT is the mean residence time.'}, {'measure': 'λz of Unconjugated Rotigotine', 'timeFrame': '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.', 'description': 'The λz is the rate constant of elimination.'}, {'measure': 't1/2 of Unconjugated Rotigotine', 'timeFrame': '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.', 'description': 'The t1/2 is the terminal half- life.'}, {'measure': 'CL/f of Unconjugated Rotigotine', 'timeFrame': '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.', 'description': 'The CL/f is the apparent total body clearance.'}, {'measure': 'Apparent Dose', 'timeFrame': '48 hours', 'description': 'Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rotigotine', 'Neupro®', 'Transdermal Patch'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '24006953', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy White, male volunteers between 18 and 55 years of age (inclusive).\n* BMI between 19 and 28 kg/m² (inclusive).\n\nExclusion Criteria:\n\n* Previous participation in a clinical study with rotigotine\n* History or current condition of epilepsy and/or seizures.\n* Known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity.\n* History of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis.\n* History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease.\n* Clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations.\n* Positive HIV, hepatitis B or C test or positive alcohol or drug test.\n* Relevant hepatic or renal dysfunction\n* Intake of medication that might interfere with the test drug within 2 weeks prior to dosing.\n* Thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites'}, 'identificationModule': {'nctId': 'NCT00881894', 'briefTitle': 'Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'Single-site, Open-label, Randomized, Cross-over Trial to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (4.5mg/10cm^2) From 2 Different Manufacturing Processes', 'orgStudyIdInfo': {'id': 'SP0951'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)', 'description': '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', 'interventionNames': ['Drug: Rotigotine transdermal patch']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)', 'description': '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', 'interventionNames': ['Drug: Rotigotine transdermal patch']}], 'interventions': [{'name': 'Rotigotine transdermal patch', 'type': 'DRUG', 'otherNames': ['Neupro®'], 'description': 'Rotigotine 4.5mg/10cm\\^2 patch applied for 24 hours', 'armGroupLabels': ['Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)', 'Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Neuss', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}