Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-11 @ 11:58 AM
Study NCT ID:
NCT02196805
Status:
COMPLETED
Last Update Posted:
2014-07-22
First Post:
2009-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers
Sponsor:
Otsuka Beijing Research Institute
Organization:
Study Overview
Official Title:
None
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:
This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1\*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1\*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: