A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers

GL Pharm Tech

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GL2907; Drug: Oxycontine CR 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01779492

GL2907-102

Details and patient eligibility

About

The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.

Full description

GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.

Enrollment: 24 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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24 participants in 2 patient groups

GL2907

Experimental group

Description:

Oxycodone HCl 20mg

Treatment:

Drug: GL2907

Oxycontine CR 10mg

Active Comparator group

Description:

Oxycodone HCl 10mg

Treatment:

Drug: Oxycontine CR 10mg