PatientsVille.com LogoPatientsVille.com

Healthy | 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

Healthy research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:GL2907once a day

Drug:Oxycontine CR 10mgtwice a day

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

GL2907Oxycodone HCl 20mg

Oxycontine CR 10mgOxycodone HCl 10mg

Study Status

Completed

Start Date: April 2013

Completed Date: August 2013

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Cmax,ss

Secondary Outcome: Tmax

Study sponsors, principal investigator, and references

Principal Investigator: Doo-Yeoun Cho, MD

Lead Sponsor: GL Pharm Tech Corporation

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01779492

Discuss Oxycontin