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

GL Pharm Tech

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GL2702 GLARS-NF1; Drug: Omix Ocas

Study type: Interventional

Funder types: Industry

Identifiers

NCT02072213

GL2702-103

Details and patient eligibility

About

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

Full description

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

Enrollment: 36 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

GL2702 GLARS-NF1 , fasted

Experimental group

Description:

Tamsulsoin 0.4mg

Treatment:

Drug: GL2702 GLARS-NF1

Omix Ocas® , fasted

Active Comparator group

Description:

Tamsulsoin 0.4mg

Treatment:

Drug: Omix Ocas

GL2702 GLARS-NF1, after meal

Experimental group

Description:

Tamsulsoin 0.4mg

Treatment:

Drug: GL2702 GLARS-NF1

Omix Ocas®, after meal

Active Comparator group

Description:

Tamsulsoin 0.4mg

Treatment:

Drug: Omix Ocas