Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03208218
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2017-06-25
Brief Title:
Crossover Study to Compare Pharmacokinetic Property of SYP-1512 Tab and Revlimid Cap in Healthy Male Volunteers
Sponsor:
Samyang Biopharmaceuticals Corporation
Organization:
Samyang Biopharmaceuticals Corporation
Study Overview
Official Title:
An Open-label Randomized Single Dose Crossover Bioequivalent Study to Compare Pharmacokinetic Property of SYP-1512 Tab and Revlimid Cap 25mg in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2017-07
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 purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap 25mg when administered a single-dose to healthy male volunteers
Detailed Description:
Healthy volunteers are administrated single-dose over the period I and II crossover of SYP-1512 Tab and Revlimid cap 25mg as of lenalidomide 25mg
Every time before and after each medication pharmacokinetic PK parameters and safety of SYP-1512 Tab and Revlimid cap 25mg is performed using a blood sample and conducting some tests vital signs physical exam ECG laboratory test etc respectively
Every time before and after each medication pharmacokinetic PK parameters and safety of SYP-1512 Tab and Revlimid cap 25mg is performed using a blood sample and conducting some tests vital signs physical exam ECG laboratory test etc respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None