Healthy Male SubjectsPhase 1NCT03639493
Bioequivalence Study of CJ-30060 in Healthy Male Volunteers
A Phase 1 study testing Exforge® tab 10/160mg, Crestor® tab 20mg and CJ-30060 10/160/20mg in people with Healthy Male Subjects, 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® 10/160mg, Crestor® 20mg 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
- Healthy Male Subjects
- What is being tested?
- Exforge® tab 10/160mg, Crestor® tab 20mg and CJ-30060 10/160/20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Apr 2018to 17 May 2018
- 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 males aged 20 to 45 years at screening
- BMI: 18 ~ 29.9kg/m^2
- Body weight ≥ 50kg
- Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding
Who cannot join
- Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease
- Subjects who have symptoms of an acute disease within 28 days before first administration
- Subjects who have clinically significant active, chronic disease
- Subjects who fall under the criteria below in laboratory test
- AST/ALT > UNL (upper normal limit) x 2
- Total bilirubin > UNL x 1.5
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- CrCL < 50mL/min
- CPK > UNL x 2.5
- Subjects with clinically significant low blood pressure at screening test (systolic blood pressure is less than 100 mmHg or diastolic blood pressure is less than 60 mmHg)
- Subjects 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: An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerabillity of CJ-30060 in Healthy Male Subjects
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg 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® 10/160mg, Crestor® 20mg in healthy male volunteers.
- Conditions
- Healthy Male Subjects
- Being tested
- Exforge® tab 10/160mg, Crestor® tab 20mg, CJ-30060 10/160/20mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exforge® tab 10/160mg, Crestor® tab 20mgDrug
Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg
CJ-30060 10/160/20mgDrug
Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | * Period 1: receive Exforge® tab 10/160mg, Crestor® tab 20mg
* Period 2: receive CJ-30060 10/160/20mg Receives: Drug: Exforge® tab 10/160mg, Crestor® tab 20mg; Drug: CJ-30060 10/160/20mg |
| Sequence 2 | Experimental | * Period 1: receive CJ-30060 10/160/20mg
* Period 2: receive Exforge® tab 10/160mg, Crestor® tab 20mg Receives: Drug: Exforge® tab 10/160mg, Crestor® tab 20mg; Drug: CJ-30060 10/160/20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of amlodipine
Measured: Up to 144 hours post-dose
Cmax of valsartan
Measured: Up to 144 hours post-dose
Cmax of rosuvastatin
Measured: Up to 144 hours post-dose
AUClast of amlodipine
Measured: Up to 144 hours post-dose
AUClast of valsartan
Measured: Up to 144 hours post-dose
AUClast of rosuvastatin
Measured: Up to 144 hours post-dose
Secondary outcomes (1)
AUCinf of amlodipine, valsaran, 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 posted21 Aug 2018
- Study start6 Apr 2018
- Primary completion4 May 2018
- Study completion17 May 2018
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.
- 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
- NCT03639493
- Sponsor's protocol ID
- CJ_EXR_103
- Status last verified
- Aug 2018
- First submitted
- 9 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. 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 Pharmacokinetics, Safety and Tolerabillity of CJ-30060 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03639493
- Acronym / sponsor ID
- CJ_EXR_103
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 21 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 compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg 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® 10/160mg, Crestor® 20mg 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 |
|---|---|---|
| Sequence 1 | Experimental | Drug: Exforge® tab 10/160mg, Crestor® tab 20mg, Drug: CJ-30060 10/160/20mg* Period 1: receive Exforge® tab 10/160mg, Crestor® tab 20mg * Period 2: receive CJ-30060 10/160/20mg |
| Sequence 2 | Experimental | Drug: Exforge® tab 10/160mg, Crestor® tab 20mg, Drug: CJ-30060 10/160/20mg* Period 1: receive CJ-30060 10/160/20mg * Period 2: receive Exforge® tab 10/160mg, Crestor® tab 20mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males aged 20 to 45 years at screening
- BMI: 18 ~ 29.9kg/m^2
- Body weight ≥ 50kg
- Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding
Key exclusion criteria (10 listed)
- Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease
- Subjects who have symptoms of an acute disease within 28 days before first administration
- Subjects who have clinically significant active, chronic disease
- Subjects who fall under the criteria below in laboratory test
- Subjects with clinically significant low blood pressure at screening test (systolic blood pressure is less than 100 mmHg or diastolic blood pressure is less than 60 mmHg)
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 10/160mg, Crestor® tab 20mgCo-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg | Drug | Sequence 1, Sequence 2 |
| CJ-30060 10/160/20mgFixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg | Drug | Sequence 1, Sequence 2 |
Primary outcome
Cmax of amlodipine
Time frame: Up to 144 hours post-dose
Cmax of valsartan
Time frame: Up to 144 hours post-dose
Cmax of rosuvastatin
Time frame: Up to 144 hours post-dose
AUClast of amlodipine
Time frame: Up to 144 hours post-dose
AUClast of valsartan
Time frame: Up to 144 hours post-dose
AUClast of rosuvastatin
Time frame: Up to 144 hours post-dose
1 secondary outcome
AUCinf of amlodipine, valsaran, 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 21 Aug 2018.
- 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 Exforge® tab 10/160mg, Crestor® tab 20mg and CJ-30060 10/160/20mg in people with Healthy Male Subjects, 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 4 inclusion and 10 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 21 Aug 2018. 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 of amlodipine (time frame: Up to 144 hours post-dose). The study lists 6 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 21 Aug 2018.