HealthyPhase 1NCT01926652
Safety and Pharmacokinetics Study of Amlodipine 10mg and Candesartan 32mg
A Phase 1 study testing candesartan cilexetil 32mg, amlodipine 10mg in people with Healthy, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with candesartan 32mg 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 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 weight >= 55kg and Body mass index (BMI) in the range of calculated IBW ±20%.
- Subjects without a hereditary problems or chronic desease.
- 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
- Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines.
- Systolic blood pressure range ≥150 mmHg or ≤ 100 mmHg or diastolic blood pressure range ≥ 95 mmHg or ≤ 60 mmHg.
- Subject with symptoms of acute disease within 14days prior to study medication dosing.
- Subjects with a history of clinically significant allergies of amlodipin or candesartan or CCB or other medicine (ex. aspirin or antibiotics).
- Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Serum creatinine > 1.2mg/dL.
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- smoking > 10 cigarettes/day.
- alcohol > 210g/week.
- Positive test results for drug test in urin or subject with history of substance abuse.
- Participation in any clinical investigation within 2 months prior to study medication dosing.
- Subjects with whole blood donation within 2 months, component blood donation within 1 month and blood transfusion within 1 month prior to study medication dosing.
- Subjects considered as unsuitable based on medical judgement by investigators.
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-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Amlodipine 10mg and Candesartan 32mg in Healthy Male Volunteers
Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with candesartan 32mg 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
Part A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.
Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.
| Study group | Role | What they receive |
|---|---|---|
| candesartan | Experimental | Single administration : candesartan cilexetil 32mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd Receives: Drug: candesartan cilexetil 32mg, amlodipine 10mg |
| amlodipine | Experimental | Single administration : amlodipine 10mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd Receives: Drug: candesartan cilexetil 32mg, amlodipine 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC, Cmax
Measured: 7days, 10days
Secondary outcomes (1)
Cmin, tmax, CL/F
Measured: 7days, 10days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startJul 2013
- 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 HealthyStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926652
- Sponsor's protocol ID
- SP-AC-001
- Status last verified
- Aug 2013
- First submitted
- 18 Aug 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Amlodipine 10mg and Candesartan 32mg in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01926652
- Acronym / sponsor ID
- SP-AC-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Aug 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 evaluate the pharmacokinetic interactions and safety between single dose of amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with candesartan 32mg 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 | Experimental | Drug: candesartan cilexetil 32mg, amlodipine 10mgSingle administration : candesartan cilexetil 32mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd |
| amlodipine | Experimental | Drug: candesartan cilexetil 32mg, amlodipine 10mgSingle administration : amlodipine 10mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male volunteers in the age between 20 and 55 years old(inclusive).
- Body weight >= 55kg and Body mass index (BMI) in the range of calculated IBW ±20%.
- Subjects without a hereditary problems or chronic desease.
- 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 (12 listed)
- Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines.
- Systolic blood pressure range ≥150 mmHg or ≤ 100 mmHg or diastolic blood pressure range ≥ 95 mmHg or ≤ 60 mmHg.
- Subject with symptoms of acute disease within 14days prior to study medication dosing.
- Subjects with a history of clinically significant allergies of amlodipin or candesartan or CCB or other medicine (ex. aspirin or antibiotics).
- Subjects with 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 10mgPart A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover. Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover. | Drug | amlodipine, candesartan |
Primary outcome
AUC, Cmax
Time frame: 7days, 10days
1 secondary outcome
Cmin, tmax, CL/F
Time frame: 7days, 10days
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 21 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 32mg, amlodipine 10mg in people with Healthy, run by Shin Poong Pharmaceutical 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 5 inclusion and 12 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 21 Aug 2013. 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?
AUC, Cmax (time frame: 7days, 10days). 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 21 Aug 2013.