HypertensionPhase 1NCT01806311
Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg
A Phase 1 study testing Candesartan32mg and Amlodipine10mg in people with Hypertension, run by HanAll BioPharma Co., Ltd. at 1 site in South Korea.
Trial summary
Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg 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
- Hypertension
- What is being tested?
- Candesartan32mg and Amlodipine10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Aug 2013
- 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, Age 20 to 45
- Subject must be willing and able to provide written informed consent to the study.
Who cannot join
- History of any significant sickness, liver system, gall bladder system, kidney, nerve system, respiratory system, blood tumor, endocrine system, urinary system, mental disease, muscloskeletal system, immunity system, the ear, nose and throat system and cardiovascular system.
- History of any significant gastrointestinal system and surgery of gastrointestinal.
- History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic.
- Over 10 tobaccos a day.
- Other condition which in the opinion of the investigator preclude endrollment into the study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam national university hospital,clinical trial center
Daejeon, Chungcheongbul-do, 301-721
About this study
Official title: An Open-label, Multiple-dose, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of amlodipine10mg and candesartan32mg in Healthy Male Volunteers
Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg in healthy male volunteers.
- Conditions
- Hypertension
- Being tested
- Candesartan32mg, Amlodipine10mg
- Keywords
- Pharmacokinetics, Safety, Male
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan32mgDrug
Amlodipine10mgDrug
| Study group | Role | What they receive |
|---|---|---|
| PartA: Candesartan, Candesartan + Amolodipine | Active comparator | Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally Receives: Drug: Candesartan32mg; Drug: Amlodipine10mg |
| PartB: Amlodipine, Amlodipine+Candesartan | Active comparator | Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally Receives: Drug: Candesartan32mg; Drug: Amlodipine10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A : AUC, Cmax of Candesartan
Measured: Over a 24-hour sampling period
Par B : AUC, Cmax of Amlodipine
Measured: Over a 24-hour sampling period
Secondary outcomes (2)
PartA: Cmin, tmax, CL/F of Candesartan
Measured: Over a 24-hour sampling period
PartB: Cmin, tmax, CL/F of Amlodipine
Measured: Over a 24-hour sampling period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2013
- Study completionAug 2013
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.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jang Hee Hong, Associate Professor, Principal investigator, Chungnam national university hospital, Clinical trial center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806311
- Sponsor's protocol ID
- HAMCAO12I_1
- Status last verified
- Feb 2014
- First submitted
- 4 Mar 2013
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dose, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of amlodipine10mg and candesartan32mg in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01806311
- Acronym / sponsor ID
- HAMCAO12I_1
- Conditions
- Hypertension
- Keywords
- Pharmacokinetics, Safety, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Mar 2013 (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.
Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg 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 |
|---|---|---|
| PartA: Candesartan, Candesartan + Amolodipine | Active comparator | Drug: Candesartan32mg, Drug: Amlodipine10mgCandesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally |
| PartB: Amlodipine, Amlodipine+Candesartan | Active comparator | Drug: Candesartan32mg, Drug: Amlodipine10mgCandesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male, Age 20 to 45
- Subject must be willing and able to provide written informed consent to the study.
Key exclusion criteria (5 listed)
- History of any significant sickness, liver system, gall bladder system, kidney, nerve system, respiratory system, blood tumor, endocrine system, urinary system, mental disease, muscloskeletal system, immunity system, the ear, nose and throat system and cardiovascular system.
- History of any significant gastrointestinal system and surgery of gastrointestinal.
- History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic.
- Over 10 tobaccos a day.
- Other condition which in the opinion of the investigator preclude endrollment into the study.
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 |
|---|---|---|
| Candesartan32mg | Drug | PartA: Candesartan, Candesartan + Amolodipine, PartB: Amlodipine, Amlodipine+Candesartan |
| Amlodipine10mg | Drug | PartA: Candesartan, Candesartan + Amolodipine, PartB: Amlodipine, Amlodipine+Candesartan |
Primary outcome
Part A : AUC, Cmax of Candesartan
Time frame: Over a 24-hour sampling period
Par B : AUC, Cmax of Amlodipine
Time frame: Over a 24-hour sampling period
2 secondary outcomes
PartA: Cmin, tmax, CL/F of Candesartan
Time frame: Over a 24-hour sampling period
PartB: Cmin, tmax, CL/F of Amlodipine
Time frame: Over a 24-hour sampling period
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 20 Apr 2025.
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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, Associate Professor principal investigator
Chungnam national university hospital, Clinical trial 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 Candesartan32mg and Amlodipine10mg in people with Hypertension, run by HanAll BioPharma Co., Ltd. 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 2 inclusion and 5 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 20 Apr 2025. 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?
Part A : AUC, Cmax of Candesartan (time frame: Over a 24-hour sampling period). 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 20 Apr 2025.