AJOU University Hospital
Suwon, Gyeonggido, South Korea
Completed
NCT Number: NCT01779492
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
The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.
Completed
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Notify MeKey information
Conditions
Age range
20 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
About this study
GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.
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
GL2907
Drugonce a day
Other names: Oxycodone HCl 20mg
Oxycontine CR 10mg
Drugtwice a day
Other names: Oxycodone HCl 10mg
Primary outcomes
-
Cmax,ss
Time frame: 48h
Pharmacokinetic of Oxycodone
-
AUCτ
Time frame: 24h
Pharmacokinetic of Oxycodone
Secondary outcomes
-
Tmax
Time frame: 48h
Pharmacokinetic of Oxycodone
-
t1/2
Time frame: 48h
Pharmacokinetic of Oxycodone
-
Vz/f
Time frame: 48h
Pharmacokinetic of Oxycodone
-
CL/F
Time frame: 48h
Pharmacokinetic of Oxycodone
-
Cmin,ss
Time frame: 48h
Pharmacokinetic of Oxycodone
-
Cave,ss
Time frame: 48h
Pharmacokinetic of Oxycodone
-
degree og fluctuation
Time frame: 48h
Pharmacokinetic of Oxycodone
(Cmax,ss-Cmin,ss)/Cave,ss
-
swing
Time frame: 48h
Pharmacokinetic of Oxycodone
(Cmax,ss-Cmin,ss)/Cmin,ss
-
R
Time frame: 48h
Pharmacokinetic of Oxycodone
Accumulation index
Sponsors and collaborators
Lead sponsor
GL Pharm Tech Corporation
Industry
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Jan 30, 2013
- Registry last updated
- Nov 13, 2014
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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