HealthyPhase 1NCT01779492
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
A Phase 1 study testing GL2907 and Oxycontine CR 10mg in people with Healthy, run by GL Pharm Tech Corporation at 1 site in South Korea.
Trial summary
The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GL2907 and Oxycontine CR 10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20~45 years old, Healthy Adult Male Subject
- Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.
Read the detailed description
GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.
- Conditions
- Healthy
- Being tested
- GL2907, Oxycontine CR 10mg
- Keywords
- Oxycodone, controlled release formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GL2907Drug
Also called Oxycodone HCl 20mg
once a day
Oxycontine CR 10mgDrug
Also called Oxycodone HCl 10mg
twice a day
| Study group | Role | What they receive |
|---|---|---|
| GL2907 | Experimental | Oxycodone HCl 20mg Receives: Drug: GL2907 |
| Oxycontine CR 10mg | Active comparator | Oxycodone HCl 10mg Receives: Drug: Oxycontine CR 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss
Pharmacokinetic of Oxycodone
Measured: 48h
AUCτ
Pharmacokinetic of Oxycodone
Measured: 24h
Secondary outcomes (9)
Tmax
Pharmacokinetic of Oxycodone
Measured: 48h
t1/2
Pharmacokinetic of Oxycodone
Measured: 48h
Vz/f
Pharmacokinetic of Oxycodone
Measured: 48h
CL/F
Pharmacokinetic of Oxycodone
Measured: 48h
Cmin,ss
Pharmacokinetic of Oxycodone
Measured: 48h
Cave,ss
Pharmacokinetic of Oxycodone
Measured: 48h
degree og fluctuation
Pharmacokinetic of Oxycodone
(Cmax,ss-Cmin,ss)/Cave,ss
Measured: 48h
swing
Pharmacokinetic of Oxycodone
(Cmax,ss-Cmin,ss)/Cmin,ss
Measured: 48h
R
Pharmacokinetic of Oxycodone
Accumulation index
Measured: 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GL Pharm Tech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doo-Yeoun Cho, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779492
- Sponsor's protocol ID
- GL2907-102
- Status last verified
- Nov 2014
- First submitted
- 28 Jan 2013
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01779492
- Acronym / sponsor ID
- GL2907-102
- Conditions
- Healthy
- Keywords
- Oxycodone, controlled release formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GL Pharm Tech CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GL2907 | Experimental | Drug: GL2907Oxycodone HCl 20mg |
| Oxycontine CR 10mg | Active comparator | Drug: Oxycontine CR 10mgOxycodone HCl 10mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20~45 years old, Healthy Adult Male Subject
- Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GL2907Also: Oxycodone HCl 20mgonce a day | Drug | GL2907 |
| Oxycontine CR 10mgAlso: Oxycodone HCl 10mgtwice a day | Drug | Oxycontine CR 10mg |
Primary outcome
Cmax,ss
Time frame: 48h
Pharmacokinetic of Oxycodone
AUCτ
Time frame: 24h
Pharmacokinetic of Oxycodone
9 secondary outcomes
Tmax
Time frame: 48h
t1/2
Time frame: 48h
Vz/f
Time frame: 48h
CL/F
Time frame: 48h
Cmin,ss
Time frame: 48h
Cave,ss
Time frame: 48h
degree og fluctuation
Time frame: 48h
swing
Time frame: 48h
R
Time frame: 48h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doo-Yeoun Cho, MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GL2907 and Oxycontine CR 10mg in people with Healthy, run by GL Pharm Tech Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax,ss (time frame: 48h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.