Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT01059903
Status:
COMPLETED
Last Update Posted:
2012-05-22
First Post:
2010-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches 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 (UCB)', '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 were collected up to 14 days after the last patch removal.', 'description': 'Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours', 'otherNumAtRisk': 49, 'otherNumAffected': 23, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours', 'otherNumAtRisk': 49, 'otherNumAffected': 26, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gingival Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Application Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Application Site Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Application Site Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Lipase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Blood Amylase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Blood Creatine Phosphokinase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pain in Jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Herpes Simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dizziness Postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], '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': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2704', 'spread': '3.1435', 'groupId': 'OG000'}, {'value': '5.4724', 'spread': '2.4755', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric LS-Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9028', 'ciLowerLimit': '0.8411', 'ciUpperLimit': '0.9690', '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), AUC(0-inf) 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% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.'}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': 'The AUC(0-tz) is the area under the 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': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26156', 'spread': '0.15594', 'groupId': 'OG000'}, {'value': '0.25774', 'spread': '0.11184', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric LS-Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9506', 'ciLowerLimit': '0.8833', 'ciUpperLimit': '1.0231', '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), AUC(0-inf) 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% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.'}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': 'The Cmax is the maximum plasma concentration.', 'unitOfMeasure': 'ng/ mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'PRIMARY', 'title': 'AUC(0- ∞) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '5.36933', 'spread': '3.17013', 'groupId': 'OG000'}, {'value': '5.56925', 'spread': '2.49370', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric LS-Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9046', 'ciLowerLimit': '0.8437', 'ciUpperLimit': '0.9699', '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), AUC(0-inf) 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% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.'}], 'paramType': 'MEAN', 'timeFrame': '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', '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': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '2.56504', 'spread': '0.88171', 'groupId': 'OG000'}, {'value': '2.66067', 'spread': '1.02321', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', '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 (Body Weight) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '412.942', 'spread': '239.918', 'groupId': 'OG000'}, {'value': '434.101', 'spread': '206.274', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', '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*h*kg/ mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'AUC(0- ∞) Norm (Apparent Dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '2.62042', 'spread': '0.88891', 'groupId': 'OG000'}, {'value': '2.71397', 'spread': '1.03223', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': '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).', 'unitOfMeasure': 'ng/ mL*h/ mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'AUC(0- ∞) Norm (Body Weight)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '420.811', 'spread': '242.327', 'groupId': 'OG000'}, {'value': '441.761', 'spread': '207.793', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': '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).', 'unitOfMeasure': 'ng*h*kg/ mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.128863', 'spread': '0.045903', 'groupId': 'OG000'}, {'value': '0.126144', 'spread': '0.046104', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': 'The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg).', 'unitOfMeasure': 'ng/ mL/ mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'Cmax, Norm (Body Weight) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '20.4935', 'spread': '11.9380', 'groupId': 'OG000'}, {'value': '20.4489', 'spread': '9.3456', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', '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': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '16.78', 'spread': '5.23', 'groupId': 'OG000'}, {'value': '15.75', 'spread': '5.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': 'The tmax is the time to reach maximum plasma concentration after patch application.', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'Mean Residence Time (MRT) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '18.473', 'spread': '1.936', 'groupId': 'OG000'}, {'value': '18.186', 'spread': '2.056', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': 'The MRT is the mean residence time.', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'Rate Constant of Elimination (λz) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.162587', 'spread': '0.033663', 'groupId': 'OG000'}, {'value': '0.165400', 'spread': '0.033405', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': 'The λz of unconjugated rotigotine is the rate constant of elimination.', 'unitOfMeasure': '1/ h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4523', 'spread': '0.9701', 'groupId': 'OG000'}, {'value': '4.3752', 'spread': '0.9677', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': 'the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz.', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}, {'type': 'SECONDARY', 'title': 'Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '1125.11', 'spread': '621.56', 'groupId': 'OG000'}, {'value': '1041.47', 'spread': '640.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': 'The CL/f of unconjugated rotigotine 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': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine PR2.2.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours'}, {'id': 'OG001', 'title': 'Rotigotine PR2.1.1', 'description': 'Rotigotine transdermal patch 4.5 mg/10 cm\\^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '1.970', 'spread': '0.637', 'groupId': 'OG000'}, {'value': '2.036', 'spread': '0.597', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': '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.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rotigotine PR2.2.1 First', 'description': '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'}, {'id': 'FG001', 'title': 'Rotigotine PR2.1.1 First', 'description': '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'}], 'periods': [{'title': 'Period 1: First Intervention- 24 Hours', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2: Washout Period (>= 5 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 3: Second Intervention- 24 Hours', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Pharmacokinetic Set (PKS)', 'achievements': [{'comment': 'Six subjects who fullfilled predefined criteria for patch adhesiveness were excluded from the PKS', 'groupId': 'FG000', 'numSubjects': '18'}, {'comment': 'Two subjects who fullfilled predefined criteria for patch adhesiveness were excluded from the PKS', 'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rotigotine PR2.2.1 First', 'description': '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'}, {'id': 'BG001', 'title': 'Rotigotine PR2.1.1 First', 'description': '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'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '35.6', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '36.3', 'spread': '11.0', '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': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '24.42', 'spread': '2.71', 'groupId': 'BG000'}, {'value': '24.16', 'spread': '2.75', 'groupId': 'BG001'}, {'value': '24.28', 'spread': '2.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.807', 'spread': '0.083', 'groupId': 'BG000'}, {'value': '1.807', 'spread': '0.058', 'groupId': 'BG001'}, {'value': '1.807', 'spread': '0.069', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meter (m)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.94', 'spread': '11.74', 'groupId': 'BG000'}, {'value': '78.88', 'spread': '9.14', 'groupId': 'BG001'}, {'value': '79.36', 'spread': '10.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogramm (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': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-15', 'studyFirstSubmitDate': '2010-01-28', 'resultsFirstSubmitDate': '2011-02-04', 'studyFirstSubmitQcDate': '2010-01-28', 'lastUpdatePostDateStruct': {'date': '2012-05-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-02-04', 'studyFirstPostDateStruct': {'date': '2010-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(0-tz) of Unconjugated Rotigotine', 'timeFrame': '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', 'description': 'The AUC(0-tz) is the area under the concentration-time curve from zero up to the last analytically quantifiable concentration.'}, {'measure': 'Cmax of Unconjugated Rotigotine', 'timeFrame': '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', 'description': 'The Cmax is the maximum plasma concentration.'}, {'measure': 'AUC(0- ∞) of Unconjugated Rotigotine', 'timeFrame': '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', 'description': 'The AUC(0- ∞) is the area under the plasma concentration-time curve from zero up to infinity'}], 'secondaryOutcomes': [{'measure': 'AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine', 'timeFrame': '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', '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 (Body Weight) of Unconjugated Rotigotine', 'timeFrame': '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', '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': 'AUC(0- ∞) Norm (Apparent Dose)', 'timeFrame': '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', 'description': '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).'}, {'measure': 'AUC(0- ∞) Norm (Body Weight)', 'timeFrame': '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', 'description': '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).'}, {'measure': 'Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine', 'timeFrame': '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', 'description': 'The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg).'}, {'measure': 'Cmax, Norm (Body Weight) of Unconjugated Rotigotine', 'timeFrame': '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', 'description': 'The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg).'}, {'measure': 'Tmax of Unconjugated Rotigotine', 'timeFrame': '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', 'description': 'The tmax is the time to reach maximum plasma concentration after patch application.'}, {'measure': 'Mean Residence Time (MRT) of Unconjugated Rotigotine', 'timeFrame': '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', 'description': 'The MRT is the mean residence time.'}, {'measure': 'Rate Constant of Elimination (λz) of Unconjugated Rotigotine', 'timeFrame': '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', 'description': 'The λz of unconjugated rotigotine is the rate constant of elimination.'}, {'measure': 'Terminal Half-Life (t1/2) of Unconjugated Rotigotine', 'timeFrame': '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', 'description': 'the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz.'}, {'measure': 'Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine', 'timeFrame': '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', 'description': 'The CL/f of unconjugated rotigotine is the apparent total body clearance.'}, {'measure': 'Apparent Dose', 'timeFrame': '24 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rotigotine', 'Neupro®', 'Transdermal Patch'], 'conditions': ['Healthy Volunteers']}, '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.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': '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'}, '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/m\\^2 (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'}, 'identificationModule': {'nctId': 'NCT01059903', 'briefTitle': 'Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches 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/10cm2) Comparing Two Different Formulations', 'orgStudyIdInfo': {'id': 'SP0987'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rotigotine PR2.2.1 first', 'description': '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', 'interventionNames': ['Drug: Rotigotine transdermal patch']}, {'type': 'EXPERIMENTAL', 'label': 'Rotigotine PR2.1.1 first', 'description': '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', 'interventionNames': ['Drug: Rotigotine transdermal patch']}], 'interventions': [{'name': 'Rotigotine transdermal patch', 'type': 'DRUG', 'otherNames': ['Neupro®'], 'description': 'Rotigotine 4.5 mg/10 cm\\^2 patch applied for 24 hours', 'armGroupLabels': ['Rotigotine PR2.1.1 first', 'Rotigotine PR2.2.1 first']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mönchengladbach', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}], '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'}}}}