HealthyPhase 1NCT02060019
Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects
A Phase 1 study testing administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg. in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Dec 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 19 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
- The weight range 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 their electrocardiography (ECG) and routine laboratory data obtained within 3 weeks prior to study drug administration
- Willing to adhere to protocol requirements and sign a informed consent form
Who cannot join
- History of clinically significant allergies including drug allergies
- History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
- History of genetic muscular disease and family history
- hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100)
- AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( > 1.5 times to normal range
- Creatinine clearance < 80mL/min
Show all 17Show fewer
- Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
- Serious injury, surgery and acute illness within 4 weeks prior to drug administration
- History of alcohol, smoking abuse
- alcohol > 21 units/week, 1 unit=10g=12.5mL of pure alcohol
- smoking > 10 cigarettes/day
- Use of any other medication, including herbal products, within the 2 weeks before dosing
- Participated in a previous clinical trial within 3 months prior to drug administration
- Subjects with whole blood donation within 2 months, component blood donation within months prior to drug administration
- Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
- Clinical laboratory test values are positive (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
- Subjects considered as unsuitable based on medical judgement by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects
This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.Drug
| Study group | Role | What they receive |
|---|---|---|
| exforge 10/160mg(amlodipine 10mg, valsartan160mg) | Experimental | 1 tablet daily for 10days Receives: Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg. |
| crestor 20mg(rosuvastatin 20mg) | Experimental | 1 tablet daily for 7days Receives: Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the drug-drug interactions of amlodipine, valsartan and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve)
after steady state (Administration of Investigational Product 7day or 10days)
Measured: 3 days
Secondary outcomes (1)
Assessment of the amlodipine, valsartan and rosuvastatin : AUCinf, tmax,ss(Time to reach Cmax,ss), t1/2
steady state (Administration of Investigational Product)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionDec 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Ran Yoon PhD, Principal investigator, Kyungpook university hostipal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060019
- Sponsor's protocol ID
- CJ_EXR_101
- Status last verified
- Dec 2016
- First submitted
- 6 Feb 2014
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02060019
- Acronym / sponsor ID
- CJ_EXR_101
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 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.
This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exforge 10/160mg(amlodipine 10mg, valsartan160mg) | Experimental | Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.1 tablet daily for 10days |
| crestor 20mg(rosuvastatin 20mg) | Experimental | Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.1 tablet daily for 7days |
Who may qualify
- Ages
- 19 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
- The weight range 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 their electrocardiography (ECG) and routine laboratory data obtained within 3 weeks prior to study drug administration
- Willing to adhere to protocol requirements and sign a informed consent form
Key exclusion criteria (17 listed)
- History of clinically significant allergies including drug allergies
- History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
- History of genetic muscular disease and family history
- hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100)
- AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( > 1.5 times to normal range
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 |
|---|---|---|
| administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg. | Drug | crestor 20mg(rosuvastatin 20mg), exforge 10/160mg(amlodipine 10mg, valsartan160mg) |
Primary outcome
Assessment of the drug-drug interactions of amlodipine, valsartan and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve)
Time frame: 3 days
after steady state (Administration of Investigational Product 7day or 10days)
1 secondary outcome
Assessment of the amlodipine, valsartan and rosuvastatin : AUCinf, tmax,ss(Time to reach Cmax,ss), t1/2
Time frame: 3 days
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 29 Dec 2016.
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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.
Young Ran Yoon PhD principal investigator
Kyungpook university hostipal
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 administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg. 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 17 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 29 Dec 2016. 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?
Assessment of the drug-drug interactions of amlodipine, valsartan and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve) (time frame: 3 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 29 Dec 2016.