NCT01779492CompletedPhase 1
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 Corporation1 site in 1 country24 target enrollmentStarted: April 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cmax,ss
Study Overview
Brief Summary
The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.
Detailed Description
GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Oxycontine CR 10mg
Active Comparator
Oxycodone HCl 10mg
Intervention: Oxycontine CR 10mg (Drug)
GL2907
Experimental
Oxycodone HCl 20mg
Intervention: GL2907 (Drug)
Outcomes
Primary Outcomes
Cmax,ss
Time Frame: 48h
Pharmacokinetic of Oxycodone
AUCτ
Time Frame: 24h
Pharmacokinetic of Oxycodone
Secondary Outcomes
- t1/2(48h)
- Vz/f(48h)
- CL/F(48h)
- Tmax(48h)
- Cmin,ss(48h)
- Cave,ss(48h)
- degree og fluctuation(48h)
- swing(48h)
- R(48h)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male VolunteersHealthyNCT01568450GL Pharm Tech Corporation24
Recruiting
Phase 1
A Study Comparing Pharmacokinetic and Safety of QL2107 and Keytruda® (Marketed in China and the United States) in Healthy AdultsTumorNCT06173011Qilu Pharmaceutical Co., Ltd.168
Recruiting
Phase 1
A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy AdultsTumorNCT06371534Qilu Pharmaceutical Co., Ltd.228
Completed
Phase 1
Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency AnaemiaIron DeficiencyAnaemiaNCT06080555Sichuan Huiyu Pharmaceutical Co., Ltd84
Completed
Phase 1
Phase 1 Clinical Trial to Investigate the Effect on the Pharmacokinetics of YH14755 Compared to Co-administration of Rosuvastatin and Metformin SR in Healthy VolunteersHealthyNCT02125227Yuhan Corporation56