Pharmacokinetics and Safety/Tolerability Profiles of DA-5... | NCT03200496

Studies
Pharmacokinetics and Safety/Tolerability Profiles of DA-5206 Versus Talion® Under Fasting and Fed States in Healthy Male Subjects

NCT03200496

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Jul 11, 2017Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

DA-5206(Fasting)
DA-5206(Fed)
TALION®

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2017Actual

Primary Completion Date

Jun 29, 2017Actual

Completion Date

Jun 29, 2017Actual

First Submitted Date

Jun 26, 2017

First Submission Date that Met QC Criteria

Jun 26, 2017

First Posted Date

Jun 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2017

Last Update Posted Date

Jul 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
TALION®	Experimental	Drug: TALION®
DA-5206(Fasting)	Experimental	Drug: DA-5206(Fasting)
DA-5206(Fed)	Experimental	Drug: DA-5206(Fed)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-5206(Fasting)	Drug	Test drug l : DA-5206(Fasting)	DA-5206(Fasting)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the plasma concentration versus time curve (AUC)	PK Parameter	0~24hr
Peak Plasma Concentration (Cmax)	PK Parameter	0~24hr

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male volunteer 19 years to 45 years
Body mass index in the range of 18 to 29 kg/m2 and body weight greater than 50 kg
The subjects personally signed and dated informed consent document after informed of all pertinent aspects of the study, fully understanding and determided spontaneously to participate

Exclusion Criteria:

Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, endocrine, urologic, immunologic, dermal, neurologic, or psychological disease or history of such disease
Subject with acute disease within 28 days before the first dose of Investigational product
Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
Subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided