Ignite Creation Date:
2024-05-06 @ 2:33 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02070796
Status:
COMPLETED
Last Update Posted:
2014-07-29
First Post:
2014-02-20
Brief Title:
Single-site Open-label Randomized Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch Comparing 2 Different Formulations
Sponsor:
UCB Pharma SA
Organization:
UCB Pharma
Study Overview
Official Title:
Single-site Open-label Randomized Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch 2 mg24 h Comparing 2 Different Formulations
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to establish Bioequivalence BE of 2 different formulations of the 2 mg24 hr 10 cm2 Rotigotine transdermal patches in Chinese subjects
Detailed Description:
Bioequivalence will be concluded if the 90 Confidence Intervals CIs for the ratio Treatment ATreatment B are fully included in the acceptance range from 08-125 for AUC0-t and AUC and within the acceptance range from 07 to 143 for Cmax
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None