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
PatientsVille.com
