HypertensionPhase 1NCT03657472
Bioequivalence Study of CJ-30061 in Healthy Male Volunteers
A Phase 1 study testing CJ-30061 and Exforge® 5/160mg & Lipitor® 20mg in people with Hypertension and Hyperlipidemia, 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-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hyperlipidemia
- What is being tested?
- CJ-30061 and Exforge® 5/160mg & Lipitor® 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Sep 2016to 9 Nov 2016
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male aged 19 to 55 years at the time of signing informed consent form.
- Subject with BMI from 19kg/m^2 to 27kg/m^2
- Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study
Who cannot join
- Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease.
- Subject who fall under the criteria below in laboratory test.
- AST/ALT, total bilirubin, GGT, Uric acid > UNL (upper normal limit) x 1.5
- CPK > UNL x 2.5
- CrCL < 60mL/min
- Subject who fall under the criteria below in Blood Pressure test (siSBP < 100mmHg/siSBP ≥ 150mmHg or siDBP < 70mmHg/siDBP ≥ 100mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers
To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- CJ-30061, Exforge® 5/160mg & Lipitor® 20mg
- 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-30061Drug
Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)
Exforge® 5/160mg & Lipitor® 20mgDrug
Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1(RTR) | Experimental | Not described Receives: Drug: CJ-30061; Drug: Exforge® 5/160mg & Lipitor® 20mg |
| Sequence 2(RRT) | Experimental | Not described Receives: Drug: CJ-30061; Drug: Exforge® 5/160mg & Lipitor® 20mg |
| Sequence 3(TRR) | Experimental | Not described Receives: Drug: CJ-30061; Drug: Exforge® 5/160mg & Lipitor® 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of amlodipine
Measured: Up to 72 hours
Cmax of valsartan
Measured: Up to 72 hours
Cmax of atorvastatin
Measured: Up to 72 hours
AUCt of amlodipine
Measured: Up to 72 hours
AUCt of valsartan
Measured: Up to 72 hours
AUCt of atorvastatin
Measured: Up to 72 hours
Secondary outcomes (14)
tmax of amlodipine
Measured: Up to 72 hours
tmax of valsartan
Measured: Up to 72 hours
tmax of atorvastatin
Measured: Up to 72 hours
t1/2 of atorvastatin
Measured: Up to 72 hours
t1/2 of amlodipine
Measured: Up to 72 hours
t1/2 of valsartan
Measured: Up to 72 hours
AUCinf of amlodipine
Measured: Up to 72 hours
AUCinf of valsartan
Measured: Up to 72 hours
AUCinf of atorvastatin
Measured: Up to 72 hours
AUCt of 2-OH atorvastatin
Measured: Up to 72 hours
Cmax of 2-OH atorvastatin
Measured: Up to 72 hours
tmax of 2-OH atorvastatin
Measured: Up to 72 hours
t1/2 of 2-OH atorvastatin
Measured: Up to 72 hours
AUCinf of 2-OH atorvastatin
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start19 Sep 2016
- Primary completion29 Oct 2016
- Study completion9 Nov 2016
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JaeWook Ko, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657472
- Sponsor's protocol ID
- CJ_EXA_103
- Status last verified
- Aug 2018
- First submitted
- 9 Aug 2018
- Last updated
- 5 Sep 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 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03657472
- Acronym / sponsor ID
- CJ_EXA_103
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 29 Oct 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 5 Sep 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-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1(RTR) | Experimental | Drug: CJ-30061, Drug: Exforge® 5/160mg & Lipitor® 20mg |
| Sequence 2(RRT) | Experimental | Drug: CJ-30061, Drug: Exforge® 5/160mg & Lipitor® 20mg |
| Sequence 3(TRR) | Experimental | Drug: CJ-30061, Drug: Exforge® 5/160mg & Lipitor® 20mg |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male aged 19 to 55 years at the time of signing informed consent form.
- Subject with BMI from 19kg/m^2 to 27kg/m^2
- Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study
Key exclusion criteria (6 listed)
- Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease.
- Subject who fall under the criteria below in laboratory test.
- Subject who fall under the criteria below in Blood Pressure test (siSBP < 100mmHg/siSBP ≥ 150mmHg or siDBP < 70mmHg/siDBP ≥ 100mmHg)
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-30061Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg) | Drug | Sequence 1(RTR), Sequence 2(RRT), Sequence 3(TRR) |
| Exforge® 5/160mg & Lipitor® 20mgReference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg | Drug | Sequence 1(RTR), Sequence 2(RRT), Sequence 3(TRR) |
Primary outcome
Cmax of amlodipine
Time frame: Up to 72 hours
Cmax of valsartan
Time frame: Up to 72 hours
Cmax of atorvastatin
Time frame: Up to 72 hours
AUCt of amlodipine
Time frame: Up to 72 hours
AUCt of valsartan
Time frame: Up to 72 hours
AUCt of atorvastatin
Time frame: Up to 72 hours
14 secondary outcomes
tmax of amlodipine
Time frame: Up to 72 hours
tmax of valsartan
Time frame: Up to 72 hours
tmax of atorvastatin
Time frame: Up to 72 hours
t1/2 of atorvastatin
Time frame: Up to 72 hours
t1/2 of amlodipine
Time frame: Up to 72 hours
t1/2 of valsartan
Time frame: Up to 72 hours
AUCinf of amlodipine
Time frame: Up to 72 hours
AUCinf of valsartan
Time frame: Up to 72 hours
AUCinf of atorvastatin
Time frame: Up to 72 hours
AUCt of 2-OH atorvastatin
Time frame: Up to 72 hours
Cmax of 2-OH atorvastatin
Time frame: Up to 72 hours
tmax of 2-OH atorvastatin
Time frame: Up to 72 hours
t1/2 of 2-OH atorvastatin
Time frame: Up to 72 hours
AUCinf of 2-OH atorvastatin
Time frame: Up to 72 hours
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 5 Sep 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.
JaeWook Ko, PhD principal investigator
Samsung Medical Center
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-30061 and Exforge® 5/160mg & Lipitor® 20mg in people with Hypertension and Hyperlipidemia, 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 6 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 5 Sep 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 72 hours). 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 5 Sep 2018.