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

January 8, 2019 updated by: GL Pharm Tech Corporation

A Randomized, Open-label, Single-dose, Four-sequence, Four -Period Crossover Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabukdo
      • Jeonju-si, Jeollabukdo, Korea, Republic of, 561-712
        • Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GL2702 GLARS-NF1 , fasted
Tamsulsoin 0.4mg
Drug: GL2702 GLARS-NF1
0.4mg once a day
Other Names:
  • Tamsulosin
Active Comparator: Omix Ocas® , fasted
Tamsulsoin 0.4mg
Drug: Omix Ocas
0.4mg once a day
Other Names:
  • Tamsulosin
Experimental: GL2702 GLARS-NF1, after meal
Tamsulsoin 0.4mg
Drug: GL2702 GLARS-NF1
0.4mg once a day
Other Names:
  • Tamsulosin
Active Comparator: Omix Ocas®, after meal
Tamsulsoin 0.4mg
Drug: Omix Ocas
0.4mg once a day
Other Names:
  • Tamsulosin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tmax
Time Frame: 48 hours
Pharmacokinetic parameter of Tamsulosin 0.4 mg
48 hours
t1/2
Time Frame: 48 hours
Pharmacokinetic parameter of Tamsulosin 0.4 mg
48 hours
Vz/F
Time Frame: 48 hours
Pharmacokinetic parameter of Tamsulosin 0.4 mg
48 hours
CL/F
Time Frame: 48 hours
Pharmacokinetic parameter of Tamsulosin 0.4 mg
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GL Pharm Tech Corporation

Investigators

  • Principal Investigator: Min-Gul Kim, MD, Chonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL2702-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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