Healthy Male SubjectsPhase 1NCT01652339
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects
A Phase 1 study testing Exforge tab. 10/160mg and Lodivixx tab. 5/160mg in people with Healthy Male Subjects, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male subjects PK parameter evaluation Safety profile evaluation Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- Exforge tab. 10/160mg and Lodivixx tab. 5/160mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Dec 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Years 20-45
- Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2
- volunteer
Who cannot join
- Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- Subject with symptoms of acute disease within 28days prior to study medication dosing
- Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug
- Subject with clinically significant active chronic disease
- Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5 ii. Total bilirubin > Upper normal limit × 1.5 iii. renal failure with Creatinine clearance < 50mL/min
- Clinically significant hypotension when screening period (SBP < 100mmHg, DBP < 60mmHg)
Show all 20Show fewer
- Positive test results for HBs Ab, HCV Ab, Syphilis regain test
- Use of any prescription medication within 14 days prior to study medication dosing
- Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
- Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
- Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and valsartan and dihydropyridine derivatives
- Subject who is not able to taking the institutional standard meal
- Subjects with whole blood donation within 60days, component blood donation within 20days
- Subjects receiving blood transfusion within 30days prior to study medication dosing
- Participation in any clinical investigation within 60days prior to study medication dosing
- Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker (cigarette > 10 cigarettes per day)
- Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice
- Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
- Continued serum potassium concentration abnormal status (on baseline visit, < 3.5mEq/L or > 5.5mEq/L)
- Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
Trial locations and contacts
1 site in 1 country.
About this study
To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male subjects
- PK parameter evaluation
- Safety profile evaluation
- Conditions
- Healthy Male Subjects
- Being tested
- Exforge tab. 10/160mg, Lodivixx tab. 5/160mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exforge tab. 10/160mgDrug
Also called - amlodipine besylate, - valsartan
Lodivixx tab. 5/160mgDrug
Also called - S-amlodipine, - valsartan
| Study group | Role | What they receive |
|---|---|---|
| Exforge tab. 10/160mg | Active comparator | * amlodipine besylate (10mg as amlodipine)
* valsartan 160mg Receives: Drug: Exforge tab. 10/160mg |
| Lodivixx tab. 5/160mg | Experimental | * S-amlodipine nicotinate (5mg as S-amlodipine)
* valsartan 160mg Receives: Drug: Lodivixx tab. 5/160mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum concentration)
Measured: - Valsartan evaluation : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr (14 points) - S-Amlodipine : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168 (17 points)
AUC(area under curve)
Measured: - Valsartan evaluation : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr (14 points) - S-Amlodipine : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168 (17 points)
Secondary outcomes (1)
Number of participants with adverse events
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days and follow-up period for maximum 6 days from the discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Male SubjectsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Gook Shin, MD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652339
- Sponsor's protocol ID
- HL-LDV-101
- Status last verified
- Mar 2013
- First submitted
- 19 Jul 2012
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Plosker GL, Robinson DM. Amlodipine/Valsartan: fixed-dose combination in hypertension. Drugs. 2008;68(3):373-81. doi: 10.2165/00003495-200868030-00008.
PubMed 18257612
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01652339
- Acronym / sponsor ID
- HL-LDV-101
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jul 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.
To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male subjects
- PK parameter evaluation
- Safety profile evaluation
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exforge tab. 10/160mg | Active comparator | Drug: Exforge tab. 10/160mg* amlodipine besylate (10mg as amlodipine) * valsartan 160mg |
| Lodivixx tab. 5/160mg | Experimental | Drug: Lodivixx tab. 5/160mg* S-amlodipine nicotinate (5mg as S-amlodipine) * valsartan 160mg |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Years 20-45
- Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2
- volunteer
Key exclusion criteria (20 listed)
- Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- Subject with symptoms of acute disease within 28days prior to study medication dosing
- Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug
- Subject with clinically significant active chronic disease
- Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5 ii. Total bilirubin > Upper normal limit × 1.5 iii. renal failure with Creatinine clearance < 50mL/min
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 tab. 10/160mgAlso: - amlodipine besylate, - valsartan | Drug | Exforge tab. 10/160mg |
| Lodivixx tab. 5/160mgAlso: - S-amlodipine, - valsartan | Drug | Lodivixx tab. 5/160mg |
Primary outcome
Cmax (maximum concentration)
Time frame: - Valsartan evaluation : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr (14 points) - S-Amlodipine : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168 (17 points)
AUC(area under curve)
Time frame: - Valsartan evaluation : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr (14 points) - S-Amlodipine : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168 (17 points)
1 secondary outcome
Number of participants with adverse events
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days and follow-up period for maximum 6 days from the discharge
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 26 Mar 2013.
- Background: PubMed 18257612Plosker GL, Robinson DM. Amlodipine/Valsartan: fixed-dose combination in hypertension. Drugs. 2008;68(3):373-81. doi: 10.2165/00003495-200868030-00008.
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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.
Jae Gook Shin, MD principal investigator
Inje University
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 Exforge tab. 10/160mg and Lodivixx tab. 5/160mg in people with Healthy Male Subjects, run by Hanlim Pharm. Co., Ltd. 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 3 inclusion and 20 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 26 Mar 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 (maximum concentration) (time frame: - Valsartan evaluation : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr (14 points) - S-Amlodipine : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168 (17 points)). 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?
On the ClinicalTrials.gov record for NCT01652339, which also lists 1 linked publication.
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 26 Mar 2013.