Healthy Adult VolunteersPhase 1NCT02058472
Pharmacokinetic/Pharmacodynamic & Safety Study of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers
A Phase 1 study testing G3041 and SEVIKAR® in people with Healthy Adult Volunteers, run by Dong-A Pharmaceutical Co., Ltd..
Trial summary
Study Design : randomized, open label, single-dose, 2-way cross-over design Phase : Phase I Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- G3041 and SEVIKAR®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to May 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers between the ages of 19 to 55 years old
- 19 ≤ BMI ≤ 27
- having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
- doctor determines to be suitable as subjects within 4 weeks ago before administration
Who cannot join
- Hypersensitivity(or history of hypersensitivity) to amlodipine and olmesartan
- Exceed 1.5 times of the upper limit of the reference range of AST, ALT, total bilirubin, γ-GT
- Excessive drinking(exceed alcohol 140g/week)
- Excessive caffeine(exceed 4cups/day) and grape fruit/orange juice(exceed 1cup/day)
- Smoking over 10 cigarettes per day
About this study
Official title: An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety Following Administration of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers
Study Design : randomized, open label, single-dose, 2-way cross-over design
Phase : Phase I
- Conditions
- Healthy Adult Volunteers
- Being tested
- G3041, SEVIKAR®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G3041Drug
SEVIKAR®Drug
| Study group | Role | What they receive |
|---|---|---|
| G3041 | Experimental | Amlodipine orotate 10mg/Olmesartan medoxomil 40mg Receives: Drug: G3041; Drug: SEVIKAR® |
| SEVIKAR® | Active comparator | Amlodipine besylate 10mg/Olmesartan medoxomil 40mg Receives: Drug: G3041; Drug: SEVIKAR® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast, Cmax
Measured: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h
Secondary outcomes (2)
tmax, t1/2, AUCinf, CL/F, Vz/F
Measured: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h
ΔAUEC24, ΔEmax, tEmax
Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- JW Ko, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058472
- Sponsor's protocol ID
- G3041_BE_I
- Status last verified
- Feb 2014
- First submitted
- 6 Feb 2014
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety Following Administration of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02058472
- Acronym / sponsor ID
- G3041_BE_I
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- Dec 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 10 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 Design : randomized, open label, single-dose, 2-way cross-over design
Phase : Phase I
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G3041 | Experimental | Drug: G3041, Drug: SEVIKAR®Amlodipine orotate 10mg/Olmesartan medoxomil 40mg |
| SEVIKAR® | Active comparator | Drug: G3041, Drug: SEVIKAR®Amlodipine besylate 10mg/Olmesartan medoxomil 40mg |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy volunteers between the ages of 19 to 55 years old
- 19 ≤ BMI ≤ 27
- having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
- doctor determines to be suitable as subjects within 4 weeks ago before administration
Key exclusion criteria (5 listed)
- Hypersensitivity(or history of hypersensitivity) to amlodipine and olmesartan
- Exceed 1.5 times of the upper limit of the reference range of AST, ALT, total bilirubin, γ-GT
- Excessive drinking(exceed alcohol 140g/week)
- Excessive caffeine(exceed 4cups/day) and grape fruit/orange juice(exceed 1cup/day)
- Smoking over 10 cigarettes per day
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 |
|---|---|---|
| G3041 | Drug | G3041, SEVIKAR® |
| SEVIKAR® | Drug | G3041, SEVIKAR® |
Primary outcome
AUClast, Cmax
Time frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h
2 secondary outcomes
tmax, t1/2, AUCinf, CL/F, Vz/F
Time frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h
ΔAUEC24, ΔEmax, tEmax
Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.
JW Ko, MD, PhD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing G3041 and SEVIKAR® in people with Healthy Adult Volunteers, run by Dong-A Pharmaceutical Co., Ltd..
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 4 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: status not confirmed, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
AUClast, Cmax (time frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h). 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 Feb 2014.