HealthyPhase 1GL2907-101NCT01568450
A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
A Phase 1 study testing Oxycodone 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. GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech. 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?
- Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Apr 2012
- 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
- ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%
Who cannot join
- ALT or AST > 1.25(Upper Normal Range)
- Total Bilirubin > 1.5 (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
Official title: A Randomized, Open-label, Single-dose, Crossover Study to Investigate The Pharmacokinetics Between a GL2907 XL 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.
GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Oxycodone XL 20mg(20mg once a day, fasted)
OxycodoneDrug
Oxycodone XL 20mg/day(20mg once a day, after high fat meal)
OxycodoneDrug
Oxycodone 20mg/day (10mg twice a day, fasted)
| Study group | Role | What they receive |
|---|---|---|
| GL2907 XL 20mg (Oxycodone 20mg, fasted) | Experimental | Not described Receives: Drug: Oxycodone |
| GL2907 XL 20mg (Oxycodone 20mg, after high fat meal) | Experimental | Not described Receives: Drug: Oxycodone |
| Oxycontin CR 10mg (Oxycodone 10mg, fasted) | Active comparator | Not described Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetic of Oxycodone
Measured: 48hr
AUC(0-24h)
Pharmacokinetic of Oxycodone
Measured: 24 hr
Secondary outcomes (5)
Tmax
Pharmacokinetic of Oxycodone
Measured: 48 hr
t1/2
Pharmacokinetic of Oxycodone
Measured: 48 hr
Vz/F
Pharmacokinetic of Oxycodone
Measured: 48 hr
CL/F
Pharmacokinetic of Oxycodone
Measured: 48 hr
Safety Monitoring
Adverse Event, Vital sign, 12-lead ECG, Physical Exam, Laboratory test
Measured: 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionApr 2012
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
- NCT01568450
- Sponsor's protocol ID
- GL2907-101
- Acronym
- GL2907-101
- Status last verified
- Jan 2013
- First submitted
- 19 Mar 2012
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Crossover Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01568450
- Acronym / sponsor ID
- GL2907-101 / GL2907-101
- 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
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 2 Apr 2012 (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.
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
- 3
| Arm | Type | Receives |
|---|---|---|
| GL2907 XL 20mg (Oxycodone 20mg, fasted) | Experimental | Drug: Oxycodone |
| GL2907 XL 20mg (Oxycodone 20mg, after high fat meal) | Experimental | Drug: Oxycodone |
| Oxycontin CR 10mg (Oxycodone 10mg, fasted) | Active comparator | Drug: Oxycodone |
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
- ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%
Key exclusion criteria (4 listed)
- ALT or AST > 1.25(Upper Normal Range)
- Total Bilirubin > 1.5 (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 |
|---|---|---|
| OxycodoneOxycodone XL 20mg(20mg once a day, fasted) | Drug | GL2907 XL 20mg (Oxycodone 20mg, fasted) |
| OxycodoneOxycodone XL 20mg/day(20mg once a day, after high fat meal) | Drug | GL2907 XL 20mg (Oxycodone 20mg, after high fat meal) |
| OxycodoneOxycodone 20mg/day (10mg twice a day, fasted) | Drug | Oxycontin CR 10mg (Oxycodone 10mg, fasted) |
Primary outcome
Cmax
Time frame: 48hr
Pharmacokinetic of Oxycodone
AUC(0-24h)
Time frame: 24 hr
Pharmacokinetic of Oxycodone
5 secondary outcomes
Tmax
Time frame: 48 hr
t1/2
Time frame: 48 hr
Vz/F
Time frame: 48 hr
CL/F
Time frame: 48 hr
Safety Monitoring
Time frame: 27 days
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 28 Jan 2013.
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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 Oxycodone 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 4 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 28 Jan 2013. 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 (time frame: 48hr). 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 28 Jan 2013.