HealthyPhase 1NCT02069821
Pharmacokinetic Interactions Between Amlodipine Besylate/Valsartan and Atorvastatin in Healthy Male Subjects
A Phase 1 study testing combination administration in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
The purpose of the study is to assess the pharmacokinetic interactions between amlodipine besylate/valsartan and atorvastatin single or co-administered in healthy 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
- Healthy
- What is being tested?
- combination administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 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
- Male volunteers in the age between 20 and 45 years old
- The weight is over 55kg and is not exceed ±20% of ideal weight Ideal weight = [height -100]*0.9
- Subjects with no history of any significant chronic disease
- Judged to be in good health on the basis of routine laboratory data obtained prior to study drug administration
- Willing to adhere to protocol requirements and sign a informed consent form
Who cannot join
- Subjects with Symptoms of acute disease within 28days prior to study medication dosing
- Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
- Subjects with a history of clinically significant allergies including drug allergies or anaphylaxis to amlodipine, valsartan and/or atorvastatin
- Subjects with a history of myopathy
- Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subject with the mean blood pressure of siDBP ≥ 150 mmHg or ≤ 90 mmHg and/or siSBP ≥ 95 mmHg or ≤ 50 mmHg at the screening visit
Show all 20Show fewer
- Subjects with abnormal HDL-cholesterol(<35mg/dL)
- Subjects with abnormal of serum potassium concentration (<3.4 mEq/L of >5.5 mEq/L in screening visit)
- Subjects with a history of drug abuse
- Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
- Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 14days prior to drug administration and OTC or vitamin within 7days prior to drug administration
- Participated in a previous clinical trial within 60 days prior to dosing
- Donated blood within 60 days prior to dosing
- Subjects with a history of alcohol abuse(over 21 units/week, 1 unit = 10 g of pure alcohol) or is difficult to stop drinking within study
- Subjects have ever smoked over 10 cigarette per day within 3 months prior to drug administration
- Subjects with a history of caffeine abuse or or is difficult to stop drinking within study
- Subjects with biliary obstruction
- Subjects with hepatic dysfunction (AST or ALT >3 times to accepted normal range)
- Subjects with moderate renal dysfunction (creatinine clearance (CLcr) < 30mL/min)
- 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
Daejeon, Jung-gu, 301-721
About this study
Official title: An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of Exforge® (Amlodipine Besylate/Valsartan) and Lipitor® (Atorvastatin Ca) in Healthy Male Volunteers
The purpose of the study is to assess the pharmacokinetic interactions between amlodipine besylate/valsartan and atorvastatin single or co-administered in healthy volunteers.
- Conditions
- Healthy
- Being tested
- combination administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination administrationDrug
combination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | single administration : amlodipine/valsartan 10/160mg, qd, 10days(oral) Receives: Drug: combination administration |
| Group B | Experimental | single administration : atorvastatin 40mg, qd, 7days(oral) Receives: Drug: combination administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate PK interaction of amlodipine and valsartan
AUCss,τ, Css,max
Measured: from pre dosing to 24hr post dose
To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin
AUCss,τ, Css,max
Measured: from pre dosing to 24hr post dose
Secondary outcomes (2)
To Evaluate PK interaction of amlodipine and valsartan
tss,max, CLss/F, Css,min
Measured: from pre dosing to 24hr post dose
To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin
tss,max, CLss/F, Css,min
Measured: from pre dosing to 24hr post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 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 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069821
- Sponsor's protocol ID
- CJ_EXA_101
- Status last verified
- Sep 2017
- First submitted
- 19 Feb 2014
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of Exforge® (Amlodipine Besylate/Valsartan) and Lipitor® (Atorvastatin Ca) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02069821
- Acronym / sponsor ID
- CJ_EXA_101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 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 the study is to assess the pharmacokinetic interactions between amlodipine besylate/valsartan and atorvastatin single or co-administered in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: combination administrationsingle administration : amlodipine/valsartan 10/160mg, qd, 10days(oral) |
| Group B | Experimental | Drug: combination administrationsingle administration : atorvastatin 40mg, qd, 7days(oral) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male volunteers in the age between 20 and 45 years old
- The weight is over 55kg and is not exceed ±20% of ideal weight Ideal weight = [height -100]*0.9
- Subjects with no history of any significant chronic disease
- Judged to be in good health on the basis of routine laboratory data obtained prior to study drug administration
- Willing to adhere to protocol requirements and sign a informed consent form
Key exclusion criteria (20 listed)
- Subjects with Symptoms of acute disease within 28days prior to study medication dosing
- Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
- Subjects with a history of clinically significant allergies including drug allergies or anaphylaxis to amlodipine, valsartan and/or atorvastatin
- Subjects with a history of myopathy
- 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 |
|---|---|---|
| combination administrationcombination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral) | Drug | Group A, Group B |
Primary outcome
To Evaluate PK interaction of amlodipine and valsartan
Time frame: from pre dosing to 24hr post dose
AUCss,τ, Css,max
To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin
Time frame: from pre dosing to 24hr post dose
AUCss,τ, Css,max
2 secondary outcomes
To Evaluate PK interaction of amlodipine and valsartan
Time frame: from pre dosing to 24hr post dose
To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin
Time frame: from pre dosing to 24hr post dose
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 12 Sep 2017.
- Individual participant dataSharing planned: No
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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 combination administration in people with Healthy, run by HK inno.N Corporation 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 20 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 12 Sep 2017. 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?
To Evaluate PK interaction of amlodipine and valsartan (time frame: from pre dosing to 24hr post dose). 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 12 Sep 2017.