Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607744
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Determine the Bioavailability of Selegiline TDS 6mg24 Hours vs EMSAM in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Comparative Pilot Bioavailability Study of a Generic Test Formulation of Selegiline TDS 6 mg24 Hours Against the Comparator EMSAM 6 mg24 Hours in Healthy Adult Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TDS
Brief Summary:
The goal of this clinical study is to obtain the bioavailability of the test patch of a generic formulation of Selegiline TDS 6mg24 hours by Corium Innovations against the comparator EMSAM and the systemic and local safety and tolerability will be also observed and evaluated
Detailed Description:
This is a pilot single-dose single-centre open-label randomised 2-way crossover study 2 treatments 2 periods and 2 sequences of a generic test formulation of Selegiline TDS 6 mg24 hours with the comparator EMSAM TDS 6 mg24 hours with at least 14 days washout period recruiting around 12 healthy male and female subjects
For each study period subjects will be admitted and confined in the clinical study site the night before the study day from at least 10 hours before dosing and they will be discharged once all PK safety and tolerability are completed at 36 hours after dosing Subjects will be required to return for subsequent PK safety and tolerability at 48- 72- and 96-hours post-dosing The clinic will follow up by telephone 7 3 days after completion of the study
Pharmacokinetic Blood Sampling
PK blood samples will be collected before dosing and at 1 2 4 6 8 10 12 14 16 18 24 30 36 48 72 96 hours after dosing
Pharmacokinetics
PK parameters include AUC0-t AUC0- Cmax tmax t½ tlag if applicable λz and Mean residence time MRT will be evaluated for Selegiline
Safety
Safety will be assessed on all subjects who participate in the study from the beginning to the end Adverse events AEs abnormal vital signs abnormal ECG results abnormal physical examination findings and abnormal clinical laboratory test results will be reviewed on a subject-to-subject basis
For each study period subjects will be admitted and confined in the clinical study site the night before the study day from at least 10 hours before dosing and they will be discharged once all PK safety and tolerability are completed at 36 hours after dosing Subjects will be required to return for subsequent PK safety and tolerability at 48- 72- and 96-hours post-dosing The clinic will follow up by telephone 7 3 days after completion of the study
Pharmacokinetic Blood Sampling
PK blood samples will be collected before dosing and at 1 2 4 6 8 10 12 14 16 18 24 30 36 48 72 96 hours after dosing
Pharmacokinetics
PK parameters include AUC0-t AUC0- Cmax tmax t½ tlag if applicable λz and Mean residence time MRT will be evaluated for Selegiline
Safety
Safety will be assessed on all subjects who participate in the study from the beginning to the end Adverse events AEs abnormal vital signs abnormal ECG results abnormal physical examination findings and abnormal clinical laboratory test results will be reviewed on a subject-to-subject basis
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