Healthy Male SubjectsPhase 1NCT03648333
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)
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..
Trial summary
To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 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 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
- 27 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jun 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
- Years 20-45
- Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2
- Volunteer for the study and sign to ICF
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 28 days prior to study medication
- Subject with 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)
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- Positive test results for HBs Ab, HCV Ab, Syphilis regain test
- Use of any prescription medication within 14 days prior to study medication
- 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 60 days, component blood donation within 20 days
- Subjects receiving blood transfusion within 30 days prior to study medication dosing
- Participation in any clinical investigation within 60 days prior to study medication dosing
- Continued excessive use of caffeine (caffeine > five cups/day), severe heavy smoker (cigarette > 10 cigarettes per day) and alcohol (alcohol>30 g/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 28 days prior to study medication dosing
- Continued serum potassium concentration abnormal status (on baseline visit, < 3.5 mEq/L or > 5.5 mEq/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
- Severe renal insufficient subjects (creatinine clearance : less than 10 mL/min)
- Severe hepatic insufficient subjects,billiary cirrhosis, biliary obstruction and cholestasis patient
- Combination with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate<60 mL/min/1.73m2)
About this study
Official title: Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects
To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults
Read the detailed description
The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
- Conditions
- Healthy Male Subjects
- Being tested
- Exforge tab. 10/160mg, Lodivixx tab. 5/160mg
- Keywords
- amlodipine, valsartan, hypertension
- Medical subject headings
- Hypertension
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 nicotinate, valsartan
| Study group | Role | What they receive |
|---|---|---|
| Lodivixx tab. 5/160mg | Experimental | S-amlodipine nicotinate (5mg as S-amlodipine), valsartan 160mg Receives: Drug: Lodivixx tab. 5/160mg |
| Exforge tab. 10/160mg | Active comparator | amlodipine besylate (10mg as amlodipine), valsartan 160mg Receives: Drug: Exforge tab. 10/160mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum concentration)
Measured: 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour
AUC(area under curve)
Measured: 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour
Secondary outcomes (1)
Number of participants with adverse events
Measured: 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study startDec 2013
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KyoungSook Kim, PhD, Study chair, Metro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648333
- Sponsor's protocol ID
- HL-LDV-103
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. 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
- NCT03648333
- Acronym / sponsor ID
- HL-LDV-103
- Conditions
- Healthy Male Subjects
- Keywords
- amlodipine, valsartan, hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Aug 2018 (actual)
- 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 valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults
Detailed description
The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lodivixx tab. 5/160mg | Experimental | Drug: Lodivixx tab. 5/160mgS-amlodipine nicotinate (5mg as S-amlodipine), valsartan 160mg |
| Exforge tab. 10/160mg | Active comparator | Drug: Exforge tab. 10/160mgamlodipine besylate (10mg as amlodipine), valsartan 160mg |
Who may qualify
- Ages
- 20 to 45 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 for the study and sign to ICF
Key exclusion criteria (23 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 28 days prior to study medication
- Subject with 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 nicotinate, valsartan | Drug | Lodivixx tab. 5/160mg |
Primary outcome
Cmax (maximum concentration)
Time frame: 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour
AUC(area under curve)
Time frame: 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour
1 secondary outcome
Number of participants with adverse events
Time frame: 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour
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 27 Aug 2018.
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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.
KyoungSook Kim, PhD study chair
Metro Hospital
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..
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 23 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 27 Aug 2018. 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?
Cmax (maximum concentration) (time frame: 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour). 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 27 Aug 2018.