Healthy Male VolunteerPhase 1NCT01776047
A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers
A Phase 1 study testing Exforge® and G-0081 in people with Healthy Male Volunteer, 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 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteer
- What is being tested?
- Exforge® and G-0081
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Sep 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male volunteers between the ages of 20 to 50 years old within the range of ±20% of IBW(Ideal Body Weight)
- 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 valsartan
- Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT
- Gastrointestinal diseases or surgeries that affect absorption of drug
- Excessive drinking(exceed 30g/week) and excessive caffeine(exceed 250mg/day)
- Smoking over 10 cigarettes per day
About this study
Study Design : randomized, open label, single-dose, 2-way cross-over design
Phase : Phase I
- Conditions
- Healthy Male Volunteer
- Being tested
- Exforge®, G-0081
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exforge®Drug
G-0081Drug
| Study group | Role | What they receive |
|---|---|---|
| Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg) | Active comparator | Exforge® 10/160 Receives: Drug: Exforge® |
| G-0081 (Amlodipine orotate 10mg / Valsratan 160mg) | Experimental | G-0081 Receives: Drug: G-0081 |
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, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h
Secondary outcomes (1)
AUCinf, Tmax, t1/2, % AUCextra
AUCinf = AUClast + Clast/λz
%AUCextra = [ (AUCinf - AUClast) / AUCinf ] ×100
t1/2 = 0.693/λz
Measured: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteerStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- K S Park, MD, PhD, Principal investigator, Head of Clinical Development, Clinical Trials Center Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776047
- Sponsor's protocol ID
- G-0081_BA_I
- Status last verified
- Jan 2013
- First submitted
- 23 Jan 2013
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01776047
- Acronym / sponsor ID
- G-0081_BA_I
- Conditions
- Healthy Male Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 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.
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 |
|---|---|---|
| Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg) | Active comparator | Drug: Exforge®Exforge® 10/160 |
| G-0081 (Amlodipine orotate 10mg / Valsratan 160mg) | Experimental | Drug: G-0081G-0081 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy male volunteers between the ages of 20 to 50 years old within the range of ±20% of IBW(Ideal Body Weight)
- 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 valsartan
- Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT
- Gastrointestinal diseases or surgeries that affect absorption of drug
- Excessive drinking(exceed 30g/week) and excessive caffeine(exceed 250mg/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 |
|---|---|---|
| Exforge® | Drug | Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg) |
| G-0081 | Drug | G-0081 (Amlodipine orotate 10mg / Valsratan 160mg) |
Primary outcome
AUClast, Cmax
Time frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h
1 secondary outcome
AUCinf, Tmax, t1/2, % AUCextra
Time frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h
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 25 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.
K S Park, MD, PhD principal investigator
Head of Clinical Development, Clinical Trials Center Severance Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exforge® and G-0081 in people with Healthy Male Volunteer, 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 3 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 25 Jan 2013. 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?
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?
AUClast, Cmax (time frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h). 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 25 Jan 2013.