HealthyPhase 1CCANCT01845272
Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate
A Phase 1 study testing candesartan cilexetil 32mg, amlodipine 10mg in people with Healthy, run by HK inno.N Corporation.
Trial summary
This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- candesartan cilexetil 32mg, amlodipine 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers in the age between 20 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 ADME of medicines
- Systolic blood pressure outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 60 to 1000 mmHg for male subjects. when screening period
- Subject with symptoms of acute disease within 14days prior to study medication dosing
- 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,AST or ALT >1.5 times to normal range or total bilirubin > 1.5times to normal range)
Show all 15Show fewer
- History of drug abuse
- History of caffeine, alcohol, smoking abuse
- caffeine(coffee,tea,coke) or grapefruit juice > 4cups/day
- smoking > 20 cigarettes/day
- alcohol > 140g/week
- Positive test results for HBs Ab, HCV Ab, Syphilis regain test
- Participation in any clinical investigation within 30days prior to study medication dosing
- Subjects with whole blood donation within 60days, component blood donation within 30days and blood transfusion within 30days prior to study medication dosing
- Subjects considered as unsuitable based on medical judgement by investigators
About this study
Official title: Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers.
This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- candesartan cilexetil 32mg, amlodipine 10mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candesartan cilexetil 32mg, amlodipine 10mgDrug
Also called atacand 32mg, norvasc 10mg
Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
candesartan cilexetil 32mg, amlodipine 10mgDrug
Also called atacand 32mg, norvasc 10mg
Treatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | single administration : candesartan cilexetil 32mg, qd, 10days(oral).
combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral). Receives: Drug: candesartan cilexetil 32mg, amlodipine 10mg |
| Part 2 | Experimental | single administration : amlodipine 10mg, qd, 10days(oral).
combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral). Receives: Drug: candesartan cilexetil 32mg, amlodipine 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the drug-drug interactions of candesartan and amlodipine
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 40 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
- NCT01845272
- Sponsor's protocol ID
- CJ_CCA_101
- Acronym
- CCA
- Status last verified
- Apr 2013
- First submitted
- 23 Apr 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. 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 Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT01845272
- Acronym / sponsor ID
- CCA / CJ_CCA_101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 3 May 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.
This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: candesartan cilexetil 32mg, amlodipine 10mgsingle administration : candesartan cilexetil 32mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral). |
| Part 2 | Experimental | Drug: candesartan cilexetil 32mg, amlodipine 10mgsingle administration : amlodipine 10mg, qd, 10days(oral). combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral). |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male volunteers in the age between 20 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 ADME of medicines
- Systolic blood pressure outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 60 to 1000 mmHg for male subjects. when screening period
- Subject with symptoms of acute disease within 14days prior to study medication dosing
- 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 32mg, amlodipine 10mgAlso: atacand 32mg, norvasc 10mgTreatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover | Drug | Part 1, Part 2 |
| candesartan cilexetil 32mg, amlodipine 10mgAlso: atacand 32mg, norvasc 10mgTreatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover | Drug | Part 1, Part 2 |
Primary outcome
Assessment of the drug-drug interactions of candesartan and amlodipine
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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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.
Jae-wook Ko, MD, PhD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing candesartan cilexetil 32mg, amlodipine 10mg in people with Healthy, run by HK inno.N Corporation.
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 3 May 2013. 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?
Results are not available in the source record.
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?
Assessment of the drug-drug interactions of candesartan and amlodipine (time frame: 10 days). 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 3 May 2013.