HypertensionPhase 1NCT02811731
Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - B
A Phase 1 study testing CKD-330 16/5mg - B and Candesartan 16mg and Amlodipine 5mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical.
Trial summary
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- CKD-330 16/5mg - B and Candesartan 16mg and Amlodipine 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Aug 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteer in the age between 19 and 45 years old.
- Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.
- Subjects without a hereditary problems and chronic disease.
- Subjects whose clinical laboratory test values are inside the accepted normal range.
- Understand the requirements of the study and voluntarily consent to participate in the study.
Who cannot join
- Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system.
- History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
- History of clinically significant allergies of amlodipine or candesartan or CCB or ARB or aspirin or antibiotic.
- Subjects with galactose intolerance.
- SBP ≥ 140 mmHg or< 90 mmHg, DBP ≥ 95 mmHg or < 60 mmHg, pulse ≥ 100 BPM.
- AST or ALT > 2*ULN, total bilirubin > 2*ULN
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- Serum Creatinine > ULN
- Previous history or present of drug abuse.
- Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing.
- Subjects treated ethical drug or herbal medicine within 2 weeks, OTC or vitamin within 1 week prior to the first dosing.
- Subjects treated IP within 2 months prior to the first dosing.
- Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
- Alcohol > 21 units/week or cannot stop drinking.
- Cigarette > 10 cigarettes/day.
- Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - LASIK, LASEK).
- Not eligible to participate for the study at the discretion of investigator.
About this study
Official title: A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-330(Fixed-dose Combination of Candesartan 16 mg and Amlodipine 5 mg) With Coadministration of the Two Separate Drugs in Healthy Male Volunteers (B)
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.
- Conditions
- Hypertension
- Being tested
- CKD-330 16/5mg - B, Candesartan 16mg and Amlodipine 5mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-330 16/5mg - BDrug
Candesartan 16mg and Amlodipine 5mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Candesartan and Amlodipine | Experimental | Candesartan 16mg and Amlodipine 5mg, PO, 1days or 22days Receives: Drug: Candesartan 16mg and Amlodipine 5mg |
| CKD-330 | Experimental | CKD-330 16/5mg - B, PO, 1days or 22days Receives: Drug: CKD-330 16/5mg - B |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
- Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
- Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Cmax
- Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
- Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Secondary outcomes (4)
AUCinf
- Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
- Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
tmax
- Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
- Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
t1/2β
- Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
- Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
CL/F
- Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
- Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startApr 2015
- Primary completionMay 2015
- Study completionAug 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 Chong Kun Dang PharmaceuticalThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jang Hee Hong, Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811731
- Sponsor's protocol ID
- 144BE15006
- Status last verified
- Jun 2016
- First submitted
- 12 Jun 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-330(Fixed-dose Combination of Candesartan 16 mg and Amlodipine 5 mg) With Coadministration of the Two Separate Drugs in Healthy Male Volunteers (B)
- ClinicalTrials.gov ID
- NCT02811731
- Acronym / sponsor ID
- 144BE15006
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Jun 2016 (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.
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of the two separate drugs 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 |
|---|---|---|
| Candesartan and Amlodipine | Experimental | Drug: Candesartan 16mg and Amlodipine 5mgCandesartan 16mg and Amlodipine 5mg, PO, 1days or 22days |
| CKD-330 | Experimental | Drug: CKD-330 16/5mg - BCKD-330 16/5mg - B, PO, 1days or 22days |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteer in the age between 19 and 45 years old.
- Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.
- Subjects without a hereditary problems and chronic disease.
- Subjects whose clinical laboratory test values are inside the accepted normal range.
- Understand the requirements of the study and voluntarily consent to participate in the study.
Key exclusion criteria (16 listed)
- Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system.
- History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
- History of clinically significant allergies of amlodipine or candesartan or CCB or ARB or aspirin or antibiotic.
- Subjects with galactose intolerance.
- SBP ≥ 140 mmHg or< 90 mmHg, DBP ≥ 95 mmHg or < 60 mmHg, pulse ≥ 100 BPM.
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 |
|---|---|---|
| CKD-330 16/5mg - B | Drug | CKD-330 |
| Candesartan 16mg and Amlodipine 5mg | Drug | Candesartan and Amlodipine |
Primary outcome
AUCt
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Cmax
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
4 secondary outcomes
AUCinf
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
tmax
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
t1/2β
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
CL/F
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
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 23 Jun 2016.
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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.
Jang Hee Hong principal investigator
Chungnam National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-330 16/5mg - B and Candesartan 16mg and Amlodipine 5mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical.
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 5 inclusion and 16 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 23 Jun 2016. 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?
AUCt (time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr). 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 23 Jun 2016.