NCT02072213

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2013

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
Last Updated

January 10, 2019

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

February 24, 2014

Last Update Submit

January 8, 2019

Conditions

Healthy

Keywords

Tamsulosin,controlled release formulation

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Pharmacokinetic parameter of tamsulosin 0.4mg

    48 hours

  • AUClast

    Pharmacokinetic parameter of Tamsulosin 0.4mg

    48 hours

Secondary Outcomes (4)

  • Tmax

    48 hours

  • t1/2

    48 hours

  • Vz/F

    48 hours

  • CL/F

    48 hours

Study Arms (4)

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

GL2702 GLARS-NF1DRUG

0.4mg once a day

Also known as: Tamsulosin
GL2702 GLARS-NF1 , fastedGL2702 GLARS-NF1, after meal
Omix OcasDRUG

0.4mg once a day

Also known as: Tamsulosin
Omix Ocas® , fastedOmix Ocas®, after meal

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabukdo, 561-712, South Korea

Location

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Min-Gul Kim, MD

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

August 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 10, 2019

Record last verified: 2014-02

Locations

KR(1)