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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Oxycontine CR 10mg; Drug: GL2907

• Registration Number: NCT01779492
• Lead Sponsor: GL Pharm Tech Corporation

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 Timeline

• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Study Start: 2013-04
• Primary Completion: 2013-06
• Study Completion: 2013-08
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxycontine CR 10mg	Oxycontine CR 10mg	Oxycodone HCl 10mg
GL2907	GL2907	Oxycodone HCl 20mg

Primary Outcome Measures

Name	Time	Method
Cmax,ss	48h	Pharmacokinetic of Oxycodone
AUCτ	24h	Pharmacokinetic of Oxycodone

Secondary Outcome Measures

Name	Time	Method
t1/2	48h	Pharmacokinetic of Oxycodone
Vz/f	48h	Pharmacokinetic of Oxycodone
CL/F	48h	Pharmacokinetic of Oxycodone
Tmax	48h	Pharmacokinetic of Oxycodone
degree og fluctuation	48h	Pharmacokinetic of Oxycodone; (Cmax,ss-Cmin,ss)/Cave,ss
swing	48h	Pharmacokinetic of Oxycodone; (Cmax,ss-Cmin,ss)/Cmin,ss
R	48h	Pharmacokinetic of Oxycodone; Accumulation index
Cmin,ss	48h	Pharmacokinetic of Oxycodone
Cave,ss	48h	Pharmacokinetic of Oxycodone

Trial Locations

Locations (1)

AJOU University Hospital; 🇰🇷 Suwon, Gyeonggido, Korea, Republic of