Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-13 @ 3:55 AM
Study NCT ID:
NCT02686294
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2016-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeated Dosing Clinical Trial of HL151
Sponsor:
Hanlim Pharm. Co., Ltd.
Organization:
Study Overview
Official Title:
Repeated Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2018-08
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 assess the pharmacokinetic characteristics of bepotastine after multiple oral administration of TALION tab., a IR formulation of bepotastine as reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
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?: