Healthy VolunteersPhase 1CCANCT02173912
Bioequivalence Study of CJ-30059
A Phase 1 study testing Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference) and CJ-30059 (Test) in people with Healthy Volunteers, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study is designed to evaluate the bioequivalence of the two treatments, the administration of CJ-30059 and the co-administration of candesartan cilexetil and amlodipine besylate, in healthy 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
- Healthy Volunteers
- What is being tested?
- Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference) and CJ-30059 (Test)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Aug 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers in the age between 19 and 55 years old(inclusive)
- Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)
- Available for the entire study period
- Understand the requirements of the study and voluntarily consent to participate in the study
Who cannot join
- Subjects with a history of gastrointestinal diseases which might significantly change absorption, distribution, metabolism and excretion (ADME) of medicines
- Systolic blood pressure outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 70 to 1000 mmHg for male subjects during screening
- Subject with symptoms of acute disease within 14days prior to study drug administration
- Subjects with a history of clinically significant allergies
- Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, aspartate aminotransferase (AST) or alamin aminotransferase (ALT) >1.5 times of the Upper Normal Limit or total bilirubin > 1.5 times of the Upper Normal Limit)
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- History of drug abuse
- History of caffeine, alcohol, smoking abuse
- caffeine(coffee, tea, coke) or grapefruit juice > 4 cups/day
- smoking > 20 cigarettes/day
- alcohol > 140 g/week
- Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test
- Participation in any clinical investigation within 30 days prior to study drug administration
- Subjects with whole blood donation within 60 days, component blood donation within 30days and blood transfusion within 30 days prior to study drug administration
- Subjects who are judged unsuitable by investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Chaeyeong Lee
Jae-Wook Ko, MD
About this study
Official title: Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety Following Administration of CJ-30059 and Co-administration of Candesartan Cilexetil and Amlodipine Besylate in Healthy Volunteers.
This study is designed to evaluate the bioequivalence of the two treatments, the administration of CJ-30059 and the co-administration of candesartan cilexetil and amlodipine besylate, in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference), CJ-30059 (Test)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference)Drug
Sequence 1 receives Candesartan cilexetil 16 mg and Amlodipine besylate 10mg first, then CJ-30059 second, with at least 14-day wash-out period in between.
Sequence 2 receives CJ-30059 first, then Candesartan cilexetil 16 mg and Amlodipine besylate 10mg second, with at least 14-day wash-out period in between.
CJ-30059 (Test)Drug
Sequence 1 receives Candesartan cilexetil 16 mg and Amlodipine besylate 10mg first, then CJ-30059 second, with at least 14-day wash-out period in between.
Sequence 2 receives CJ-30059 first, then Candesartan cilexetil 16 mg and Amlodipine besylate 10mg second, with at least 14-day wash-out period in between.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Single-dose crossover
1. Test: CJ-30059
2. Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg
Once daily Oral administration with at least 14 days of washout period Receives: Drug: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference); Drug: CJ-30059 (Test) |
| Sequence 2 | Experimental | Single-dose crossover
1. Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg
2. Test: CJ-30059
Once daily Oral administration with at least 14 days of washout period Receives: Drug: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference); Drug: CJ-30059 (Test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the plasma concentration-time Curve (AUC_last) of Amlodipine
Measured: Upto 72 hours
Area Under the plasma concentration-time Curve (AUC_last) of Candesartan
Measured: Upto 72 hours
Maximum plasma concentration (Cmax) of Amlodipine
Measured: Upto 72 hours
Maximum plasma concentration (Cmax) of Candesartan
Measured: Upto 72 hours
Secondary outcomes (4)
Time to maximum plasma concentration of Amlodipine
Measured: Upto 72 hours
Time to maximum plasma concentration of Candesartan
Measured: Upto 72 hours
Elimination half-lie of Amlodipine
Measured: Upto 72 hours
Elimination half-lie of Candesartan
Measured: Upto 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae-wook Ko, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173912
- Sponsor's protocol ID
- CJ_CCA_102
- Acronym
- CCA
- Status last verified
- Jun 2014
- First submitted
- 24 Jun 2014
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety Following Administration of CJ-30059 and Co-administration of Candesartan Cilexetil and Amlodipine Besylate in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02173912
- Acronym / sponsor ID
- CCA / CJ_CCA_102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 25 Jun 2014 (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.
This study is designed to evaluate the bioequivalence of the two treatments, the administration of CJ-30059 and the co-administration of candesartan cilexetil and amlodipine besylate, in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference), Drug: CJ-30059 (Test)Single-dose crossover 1. Test: CJ-30059 2. Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg Once daily Oral administration with at least 14 days of washout period |
| Sequence 2 | Experimental | Drug: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference), Drug: CJ-30059 (Test)Single-dose crossover 1. Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg 2. Test: CJ-30059 Once daily Oral administration with at least 14 days of washout period |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male volunteers in the age between 19 and 55 years old(inclusive)
- Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)
- Available for the entire study period
- Understand the requirements of the study and voluntarily consent to participate in the study
Key exclusion criteria (15 listed)
- Subjects with a history of gastrointestinal diseases which might significantly change absorption, distribution, metabolism and excretion (ADME) of medicines
- Systolic blood pressure outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 70 to 1000 mmHg for male subjects during screening
- Subject with symptoms of acute disease within 14days prior to study drug administration
- Subjects with a history of clinically significant allergies
- Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
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 |
|---|---|---|
| Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference)Sequence 1 receives Candesartan cilexetil 16 mg and Amlodipine besylate 10mg first, then CJ-30059 second, with at least 14-day wash-out period in between. Sequence 2 receives CJ-30059 first, then Candesartan cilexetil 16 mg and Amlodipine besylate 10mg second, with at least 14-day wash-out period in between. | Drug | Sequence 1, Sequence 2 |
| CJ-30059 (Test)Sequence 1 receives Candesartan cilexetil 16 mg and Amlodipine besylate 10mg first, then CJ-30059 second, with at least 14-day wash-out period in between. Sequence 2 receives CJ-30059 first, then Candesartan cilexetil 16 mg and Amlodipine besylate 10mg second, with at least 14-day wash-out period in between. | Drug | Sequence 1, Sequence 2 |
Primary outcome
Area Under the plasma concentration-time Curve (AUC_last) of Amlodipine
Time frame: Upto 72 hours
Area Under the plasma concentration-time Curve (AUC_last) of Candesartan
Time frame: Upto 72 hours
Maximum plasma concentration (Cmax) of Amlodipine
Time frame: Upto 72 hours
Maximum plasma concentration (Cmax) of Candesartan
Time frame: Upto 72 hours
4 secondary outcomes
Time to maximum plasma concentration of Amlodipine
Time frame: Upto 72 hours
Time to maximum plasma concentration of Candesartan
Time frame: Upto 72 hours
Elimination half-lie of Amlodipine
Time frame: Upto 72 hours
Elimination half-lie of Candesartan
Time frame: Upto 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
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Healthy Participants
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-wook Ko, MD, 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 Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference) and CJ-30059 (Test) in people with Healthy Volunteers, 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 15 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: status not confirmed, as of the sponsor's last update on 25 Jun 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geun-Seog Song, PhD (82-2-6740-2440, kssong1212@cj.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the plasma concentration-time Curve (AUC_last) of Amlodipine (time frame: Upto 72 hours). The study lists 4 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 25 Jun 2014.