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NCT Number: NCT02072213

A PK Study 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

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Jeonju, Jeollabukdo, 561-712, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GL2702 GLARS-NF1

Drug

0.4mg once a day

Other names: Tamsulosin

Omix Ocas

Drug

0.4mg once a day

Other names: Tamsulosin

Primary outcomes

  1. Cmax

    Time frame: 48 hours

    Pharmacokinetic parameter of tamsulosin 0.4mg

  2. AUClast

    Time frame: 48 hours

    Pharmacokinetic parameter of Tamsulosin 0.4mg

Secondary outcomes

  1. Tmax

    Time frame: 48 hours

    Pharmacokinetic parameter of Tamsulosin 0.4 mg

  2. t1/2

    Time frame: 48 hours

    Pharmacokinetic parameter of Tamsulosin 0.4 mg

  3. Vz/F

    Time frame: 48 hours

    Pharmacokinetic parameter of Tamsulosin 0.4 mg

  4. CL/F

    Time frame: 48 hours

    Pharmacokinetic parameter of Tamsulosin 0.4 mg

Sponsors and collaborators

Lead sponsor

GL Pharm Tech Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2014
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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