HypertensionPhase 1CKD-330(A)NCT02064556
CKD-330 Drug-Drug Interaction Study (Amlodipine)
A Phase 1 study testing Amlodipine 10mg and Amlodipine 10mg/Candesartan 32mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine monotherapy. 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
- What is being tested?
- Amlodipine 10mg and Amlodipine 10mg/Candesartan 32mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Jul 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening).
- Volunteer who has 19kg/m² ≤ BMI(Body Mass Index) ≤ 26kg/m²
- When volunteer in screening, Must include under the items.
- 100 mmHg ≤ sitting SBP <140 mmHg
- 60 mmHg ≤ sitting DBP < 90 mmHg
- 45 bpm ≤ Pulse < 95 bpm
- Those who decided to join the clinical trials by themselves and to comply with the precautions written consent.
Who cannot join
- A previous history or present of clinically significant liver, renal, gastro-intestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, cardiovascular disease.
- Have a gastrointestinal disease history that can affect drug absorption(Crohn's disease, Ulcers, GERD, Gastritis, etc.) or surgery (except simple appendectomy or hernia surgery).
- The history of clinically significant hypersensitivity reaction about Investigational drugs and foods.
- The history of drug abuse or drug abuse showed a positive for urine drug test.
- Taking drugs have received any other investigational drug within 90 days prior to the first dosing and metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing.
- Whole blood donation within 60 days prior to the first dosing or plasma donation within 30 days prior to the first dosing.
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- Taking drugs that clinical trials expected to affect within 14days or taking food containing caffeine, grapefruit within 7days before the first dosing.
- A heavy alcohol consumer(alcohol>3cup/day or 3times/week within last 1month)
- A heavy smoker(cigarette>10cigarettes/day)
- The subject has positive results of serum tests(Hepatitis B, C, HIV Test, Syphilis).
- Have the Liver enzyme levels(AST, ALT) or Bilirubin, total results greater than 1.5 times the UNL.
- Have the result of Creatinine clearance is less than 80mL/min(Cockcroft-Gault equation applicable).
- The result of 12-lead ECG in screening test is QTc>450msec.
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Amlodipine Between Free Combination of Amlodipine and Candesartan and Amlodipine Monotherapy in Healthy Male Volunteers
The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine monotherapy.
- Conditions
- Hypertension
- Being tested
- Amlodipine 10mg, Amlodipine 10mg/Candesartan 32mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine 10mgDrug
Also called Norvasc Tab. 10mg
Amlodipine 10mg 1T, PO, QD for 9days
Amlodipine 10mg/Candesartan 32mgDrug
Also called Norvasc Tab. 10mg/Atacand Tab. 32mg
Amlodipine 10mg 1T, PO, QD for 9days/Candesartan 32mg 1T, PO, QD for 9days
| Study group | Role | What they receive |
|---|---|---|
| A(Amlodipine 10mg) | Experimental | Amlodipine 10mg 1T, PO, QD for 9days Receives: Drug: Amlodipine 10mg/Candesartan 32mg |
| B(Amlodipine 10mg/Candesartan 32mg) | Experimental | Amlodipine 10mg 1T, PO, QD for 9days/Candesartan 32mg 1T, PO, QD for 9days Receives: Drug: Amlodipine 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss of Amlodipine
Measured: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h
Cmax,ss of Amlodipine
Measured: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h
Secondary outcomes (1)
Tmax,ss of Amlodipine
Measured: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionJul 2014
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyun-Seop Bae, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064556
- Sponsor's protocol ID
- 144HPS13012
- Acronym
- CKD-330(A)
- Status last verified
- Aug 2014
- First submitted
- 14 Feb 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Amlodipine Between Free Combination of Amlodipine and Candesartan and Amlodipine Monotherapy in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02064556
- Acronym / sponsor ID
- CKD-330(A) / 144HPS13012
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Feb 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.
The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(Amlodipine 10mg) | Experimental | Drug: Amlodipine 10mg/Candesartan 32mgAmlodipine 10mg 1T, PO, QD for 9days |
| B(Amlodipine 10mg/Candesartan 32mg) | Experimental | Drug: Amlodipine 10mgAmlodipine 10mg 1T, PO, QD for 9days/Candesartan 32mg 1T, PO, QD for 9days |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening).
- Volunteer who has 19kg/m² ≤ BMI(Body Mass Index) ≤ 26kg/m²
- When volunteer in screening, Must include under the items.
- Those who decided to join the clinical trials by themselves and to comply with the precautions written consent.
Key exclusion criteria (14 listed)
- A previous history or present of clinically significant liver, renal, gastro-intestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, cardiovascular disease.
- Have a gastrointestinal disease history that can affect drug absorption(Crohn's disease, Ulcers, GERD, Gastritis, etc.) or surgery (except simple appendectomy or hernia surgery).
- The history of clinically significant hypersensitivity reaction about Investigational drugs and foods.
- The history of drug abuse or drug abuse showed a positive for urine drug test.
- Taking drugs have received any other investigational drug within 90 days prior to the first dosing and metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing.
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 |
|---|---|---|
| Amlodipine 10mgAlso: Norvasc Tab. 10mgAmlodipine 10mg 1T, PO, QD for 9days | Drug | B(Amlodipine 10mg/Candesartan 32mg) |
| Amlodipine 10mg/Candesartan 32mgAlso: Norvasc Tab. 10mg/Atacand Tab. 32mgAmlodipine 10mg 1T, PO, QD for 9days/Candesartan 32mg 1T, PO, QD for 9days | Drug | A(Amlodipine 10mg) |
Primary outcome
AUCτ,ss of Amlodipine
Time frame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h
Cmax,ss of Amlodipine
Time frame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h
1 secondary outcome
Tmax,ss of Amlodipine
Time frame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h
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 15 Aug 2014.
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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.
Kyun-Seop Bae, Professor principal investigator
Asan 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 Amlodipine 10mg and Amlodipine 10mg/Candesartan 32mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical 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 7 inclusion and 14 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 15 Aug 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?
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?
AUCτ,ss of Amlodipine (time frame: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h). 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 15 Aug 2014; AzTrials last refreshed its copy on 3 Nov 2026.