A PK Study GL2702 GLARS-NF1 and Omix Ocas® in Healthy Mal... | NCT02072213

Studies
A PK Study GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers

NCT02072213

Sponsor

GL Pharm Tech Corporation

Status

Completed

Last Update Posted

Jan 10, 2019Actual

Enrollment

36Actual

Phase

Phase 1

Conditions

Healthy

Interventions

GL2702 GLARS-NF1
Omix Ocas

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

Feb 2014

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

Aug 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Feb 24, 2014

First Posted Date

Feb 26, 2014Estimated

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

Jan 8, 2019

Last Update Posted Date

Jan 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers

Detailed Description

GL2702 GLARS-NF1 tablet is controlled released formulation which is invented by GL Pharm Tech Corp.

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

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GL2702 GLARS-NF1 , fasted	Experimental	Tamsulsoin 0.4mg	Drug: GL2702 GLARS-NF1
Omix Ocas® , fasted	Active Comparator	Tamsulsoin 0.4mg	Drug: Omix Ocas
GL2702 GLARS-NF1, after meal	Experimental	Tamsulsoin 0.4mg	Drug: GL2702 GLARS-NF1
Omix Ocas®, after meal	Active Comparator	Tamsulsoin 0.4mg	Drug: Omix Ocas

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GL2702 GLARS-NF1	Drug	0.4mg once a day	GL2702 GLARS-NF1 , fasted GL2702 GLARS-NF1, after meal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax	Pharmacokinetic parameter of tamsulosin 0.4mg	48 hours
AUClast	Pharmacokinetic parameter of Tamsulosin 0.4mg	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Tmax	Pharmacokinetic parameter of Tamsulosin 0.4 mg	48 hours
t1/2	Pharmacokinetic parameter of Tamsulosin 0.4 mg	48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20~45 years old, Healthy Adult Male Subject
Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

ALT or AST > 1.25 times (Upper Normal Range)
Total Bilirubin > 1.5 times (Upper Normal Range)
CPK > 2 times (Upper Normal Range)
BUN or Creatinine > Normal Range
Systolic BP > 160mmHg or < 80mmHg, Diastolic BP > 100mmHg or < 50mmHg

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Min-Gul Kim, MD	Chonbuk National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chonbuk National University Hospital		Jeonju	Jeollabukdo	561-712	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000077409	Tamsulosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided