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
NCT01779492 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2014-11-13
Summary
The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.
Conditions
- Healthy
Interventions
- DRUG
-
GL2907
once a day
- DRUG
-
Oxycontine CR 10mg
twice a day
Sponsors & Collaborators
-
GL Pharm Tech Corporation
lead INDUSTRY
Principal Investigators
-
Doo-Yeoun Cho, MD · Ajou University School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2013-06-30
- Completion
- 2013-08-31
Countries
- South Korea
Study Locations
More Related Trials
-
Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions
NCT02059915 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
NCT01677065 ·Status: COMPLETED
-
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
NCT01101191 ·Status: COMPLETED ·Phase: PHASE1
-
Fed Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
NCT00853736 ·Status: COMPLETED ·Phase: PHASE1
-
OTR Tablet 40 mg Fasted-state Bioequivalence Study
NCT03398278 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
NCT01100086 ·Status: COMPLETED ·Phase: PHASE1
-
Fasting Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
NCT00853216 ·Status: COMPLETED ·Phase: PHASE1
-
Fasting Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets
NCT00853892 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
NCT01101308 ·Status: COMPLETED ·Phase: PHASE1
-
Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions
NCT02089295 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
NCT01099709 ·Status: COMPLETED ·Phase: PHASE1
-
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
NCT01101165 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
NCT01530542 ·Status: COMPLETED ·Phase: PHASE1
-
OTR Tablet 40 mg Fed-state Bioequivalence Study
NCT03398330 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions
NCT00857142 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics And Relative Bioavailability Study Of Oxycodone
NCT01552850 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
NCT01100320 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers
NCT01552863 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment
NCT02242734 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions
NCT01210638 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers
NCT02259179 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions
NCT00857428 ·Status: COMPLETED ·Phase: PHASE1
-
Open-Label Trial Comparing Oxycodone Medications
NCT01162304 ·Status: TERMINATED ·Phase: PHASE4
-
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults
NCT03137017 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults
NCT03137030 ·Status: WITHDRAWN ·Phase: PHASE1