HypertensionPhase 1NCT03009474
Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers
A Phase 1 study testing CJ-30060 and Exforge tab 5/160mg, Crestor tab 10mg in people with Hypertension and Hyperlipidemias, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg 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
- Hypertension, Hyperlipidemias
- What is being tested?
- CJ-30060 and Exforge tab 5/160mg, Crestor tab 10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to Apr 2015
- 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
- Healthy male aged 20 to 45 years at the screening
- Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive)
- Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.
Who cannot join
- Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease.
- Subject who have symptoms, result from acute disease within 28days before first administration.
- Subject who have chronic persisting disease with clinical significance.
- Subject who fall under the criteria below in laboratory test.
- AST/ALT > UNL (upper normal limit) x 2
- Total bilirubin > UNL x 1.5
Show all 11Show fewer
- In case of renal failure that creatine clearance is less than 50mL/min according to Cockcroft-Gault
- CPK > UNL x 2.5
- Subject who with low blood pressure with clinical significance at screening test.
- (systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60 mmHg)
- Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Assess the Pharmacokinetic Characteristics of CJ-30060 in Healthy Male Subjects
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
Read the detailed description
The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
- Conditions
- Hypertension, Hyperlipidemias
- Being tested
- CJ-30060, Exforge tab 5/160mg, Crestor tab 10mg
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-30060Drug
Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg
Exforge tab 5/160mg, Crestor tab 10mgDrug
Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg
| Study group | Role | What they receive |
|---|---|---|
| CJ-30060 | Experimental | Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg Receives: Drug: Exforge tab 5/160mg, Crestor tab 10mg |
| Exforge tab 5/160mg, Crestor tab 10mg | Active comparator | Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg Receives: Drug: CJ-30060 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin
Measured: Up to 144 hours post-dose
Secondary outcomes (5)
Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin
Measured: Up to 144 hours post-dose
Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin
Measured: Up to 144 hours post-dose
Half life (t1/2) of amlodipine, valsartan, rosuvastatin
Measured: Up to 144 hours post-dose
Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin
Measured: Up to 144 hours post-dose
Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin
Measured: Up to 144 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ji Young Park, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009474
- Sponsor's protocol ID
- CJ_EXR_102
- Status last verified
- Jan 2017
- First submitted
- 11 Mar 2015
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Pharmacokinetic Characteristics of CJ-30060 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03009474
- Acronym / sponsor ID
- CJ_EXR_102
- Conditions
- Hypertension, Hyperlipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Jan 2017 (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 compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
Detailed description
The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CJ-30060 | Experimental | Drug: Exforge tab 5/160mg, Crestor tab 10mgAmlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg |
| Exforge tab 5/160mg, Crestor tab 10mg | Active comparator | Drug: CJ-30060Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male aged 20 to 45 years at the screening
- Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive)
- Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.
Key exclusion criteria (11 listed)
- Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease.
- Subject who have symptoms, result from acute disease within 28days before first administration.
- Subject who have chronic persisting disease with clinical significance.
- Subject who fall under the criteria below in laboratory test.
- Subject who with low blood pressure with clinical significance at screening test.
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 |
|---|---|---|
| CJ-30060Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg | Drug | Exforge tab 5/160mg, Crestor tab 10mg |
| Exforge tab 5/160mg, Crestor tab 10mgCo-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg | Drug | CJ-30060 |
Primary outcome
Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
5 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
Half life (t1/2) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin
Time frame: Up to 144 hours post-dose
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 4 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Ji Young Park, PhD principal investigator
Korea University Anam 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 CJ-30060 and Exforge tab 5/160mg, Crestor tab 10mg in people with Hypertension and Hyperlipidemias, run by HK inno.N 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 3 inclusion and 11 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 4 Jan 2017. 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?
Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin (time frame: Up to 144 hours post-dose). 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 4 Jan 2017.