HealthyPhase 1NCT02072213
A PK Study GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
A Phase 1 study testing GL2702 GLARS-NF1 and Omix Ocas in people with Healthy, run by GL Pharm Tech Corporation at 1 site in South Korea.
Trial summary
Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers 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?
- GL2702 GLARS-NF1 and Omix Ocas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Jan 2014
- 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.
South Korea1 site
Chonbuk National University Hospital
Jeonju, Jeollabukdo, 561-712
About this study
Official title: A Randomized, Open-label, Single-dose, Four-sequence, Four -Period Crossover Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
Read the detailed description
GL2702 GLARS-NF1 tablet is controlled released formulation which is invented by GL Pharm Tech Corp.
- Conditions
- Healthy
- Being tested
- GL2702 GLARS-NF1, Omix Ocas
- Keywords
- Tamsulosin,controlled release formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GL2702 GLARS-NF1Drug
Also called Tamsulosin
0.4mg once a day
Omix OcasDrug
Also called Tamsulosin
0.4mg once a day
| Study group | Role | What they receive |
|---|---|---|
| GL2702 GLARS-NF1 , fasted | Experimental | Tamsulsoin 0.4mg Receives: Drug: GL2702 GLARS-NF1 |
| Omix Ocas® , fasted | Active comparator | Tamsulsoin 0.4mg Receives: Drug: Omix Ocas |
| GL2702 GLARS-NF1, after meal | Experimental | Tamsulsoin 0.4mg Receives: Drug: GL2702 GLARS-NF1 |
| Omix Ocas®, after meal | Active comparator | Tamsulsoin 0.4mg Receives: Drug: Omix Ocas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetic parameter of tamsulosin 0.4mg
Measured: 48 hours
AUClast
Pharmacokinetic parameter of Tamsulosin 0.4mg
Measured: 48 hours
Secondary outcomes (4)
Tmax
Pharmacokinetic parameter of Tamsulosin 0.4 mg
Measured: 48 hours
t1/2
Pharmacokinetic parameter of Tamsulosin 0.4 mg
Measured: 48 hours
Vz/F
Pharmacokinetic parameter of Tamsulosin 0.4 mg
Measured: 48 hours
CL/F
Pharmacokinetic parameter of Tamsulosin 0.4 mg
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionJan 2014
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- GL Pharm Tech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Gul Kim, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072213
- Sponsor's protocol ID
- GL2702-103
- Status last verified
- Feb 2014
- First submitted
- 24 Feb 2014
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Four-sequence, Four -Period Crossover Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02072213
- Acronym / sponsor ID
- GL2702-103
- Conditions
- Healthy
- Keywords
- Tamsulosin,controlled release formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GL Pharm Tech CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Feb 2014 (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.
Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
Detailed description
GL2702 GLARS-NF1 tablet is controlled released formulation which is invented by GL Pharm Tech Corp.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GL2702 GLARS-NF1 , fasted | Experimental | Drug: GL2702 GLARS-NF1Tamsulsoin 0.4mg |
| Omix Ocas® , fasted | Active comparator | Drug: Omix OcasTamsulsoin 0.4mg |
| GL2702 GLARS-NF1, after meal | Experimental | Drug: GL2702 GLARS-NF1Tamsulsoin 0.4mg |
| Omix Ocas®, after meal | Active comparator | Drug: Omix OcasTamsulsoin 0.4mg |
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 |
|---|---|---|
| GL2702 GLARS-NF1Also: Tamsulosin0.4mg once a day | Drug | GL2702 GLARS-NF1 , fasted, GL2702 GLARS-NF1, after meal |
| Omix OcasAlso: Tamsulosin0.4mg once a day | Drug | Omix Ocas® , fasted, Omix Ocas®, after meal |
Primary outcome
Cmax
Time frame: 48 hours
Pharmacokinetic parameter of tamsulosin 0.4mg
AUClast
Time frame: 48 hours
Pharmacokinetic parameter of Tamsulosin 0.4mg
4 secondary outcomes
Tmax
Time frame: 48 hours
t1/2
Time frame: 48 hours
Vz/F
Time frame: 48 hours
CL/F
Time frame: 48 hours
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 10 Jan 2019.
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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.
Min-Gul Kim, MD principal investigator
Chonbuk National University Hospital
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 GL2702 GLARS-NF1 and Omix Ocas 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 10 Jan 2019. 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: 48 hours). 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 10 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.