HealthyPhase 1NCT01925300
Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin
A Phase 1 study testing Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab and Concor 5mg 2T and Crestor 20 mg 1Tab in people with Healthy, run by HK inno.N Corporation.
Trial summary
This study is designated to evaluate the pharmacokinetic interactions of bisoprolol and rosuvastatin 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?
- Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab and Concor 5mg 2T and Crestor 20 mg 1Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Sep 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)
- Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 150 mmHg, 60 mmHg ≤ diastolic blood pressure ≤ 100 mmHg, 50 beats per minute ≤ pulse rate ≤ 100 beats per minute)
- 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(Absorption, Distribution, Metabolism and Excretion) of medicines
- History of clinically significant arrhythmic, peripheral vascular,thyroid, bronchospasm, asthma disease
- Subjects with anaphylaxis to bisoprolol and/or rosuvastatin
- History of drug abuse
- History of caffeine, alcohol, smoking abuse
- caffeine(coffee,tea,coke) or grapefruit juice > 4cups/day
Show all 14Show fewer
- smoking > 20 cigarettes/day
- alcohol > 140g/week
- Clinical laboratory test values are outside the accepted normal range
- AST(Aspartate Transaminase), ALT(ALanine Transaminase)( > 1.5 times to normal range
- CK(Creatine Kinase) > 1.5 times to normal range
- Estimated GFR(Glomerular Filtration Rate) < 60 mL/min
- 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: A Randomized, Open-label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Bisoprolol and Rosuvastatin in Healthy Adult Volunteers
This study is designated to evaluate the pharmacokinetic interactions of bisoprolol and rosuvastatin in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab, Concor 5mg 2T and Crestor 20 mg 1Tab
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concor 5mg(Bisoprolol hemifumarate 5mg) 2TabDrug
Crestor 20mg(Rosuvastatin calcium 20.80mg) 1TabDrug
Concor 5mg 2T and Crestor 20 mg 1TabDrug
| Study group | Role | What they receive |
|---|---|---|
| Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, qd | Experimental | Single administration : 6 days, per oral Receives: Drug: Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab |
| Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab, qd | Experimental | Single administration : 6 days, per oral Receives: Drug: Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab |
| Concor 5mg 2T and Crestor 20 mg 1Tab, qd | Experimental | Combination administration : 6 days, per oral Receives: Drug: Concor 5mg 2T and Crestor 20 mg 1Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the drug-drug interactions of bisoprolol and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve)
Administration of Investigational Product : 6 days/period(total 3 period)
Measured: 6 days
Secondary outcomes (1)
Assessment of the bisoprolol and rosuvastatin:tmax,ss(Time to reach Cmax,ss), t1/2, Cmin,ss(Minimum steady-state plasma drug concentration during a dosage interval ), CL/Fss(Oral Clearance), Vd/Fss(Apparent Volume of Distribution)
Administration of Investigational Product : 6 days/period(total 3 period)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae-wook Ko, phD, Principal investigator, Samsung Medical Conter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925300
- Sponsor's protocol ID
- CJ_BCS_101
- Status last verified
- Dec 2016
- First submitted
- 15 Aug 2013
- 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 Randomized, Open-label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Bisoprolol and Rosuvastatin in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01925300
- Acronym / sponsor ID
- CJ_BCS_101
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 19 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.
This study is designated to evaluate the pharmacokinetic interactions of bisoprolol and rosuvastatin in healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, qd | Experimental | Drug: Concor 5mg(Bisoprolol hemifumarate 5mg) 2TabSingle administration : 6 days, per oral |
| Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab, qd | Experimental | Drug: Crestor 20mg(Rosuvastatin calcium 20.80mg) 1TabSingle administration : 6 days, per oral |
| Concor 5mg 2T and Crestor 20 mg 1Tab, qd | Experimental | Drug: Concor 5mg 2T and Crestor 20 mg 1TabCombination administration : 6 days, per oral |
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 mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)
- Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 150 mmHg, 60 mmHg ≤ diastolic blood pressure ≤ 100 mmHg, 50 beats per minute ≤ pulse rate ≤ 100 beats per minute)
- Available for the entire study period
- Understand the requirements of the study and voluntarily consent to participate in the study
Key exclusion criteria (14 listed)
- Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
- History of clinically significant arrhythmic, peripheral vascular,thyroid, bronchospasm, asthma disease
- Subjects with anaphylaxis to bisoprolol and/or rosuvastatin
- History of drug abuse
- History of caffeine, alcohol, smoking abuse
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 |
|---|---|---|
| Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab | Drug | Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, qd |
| Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab | Drug | Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab, qd |
| Concor 5mg 2T and Crestor 20 mg 1Tab | Drug | Concor 5mg 2T and Crestor 20 mg 1Tab, qd |
Primary outcome
Assessment of the drug-drug interactions of bisoprolol and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve)
Time frame: 6 days
Administration of Investigational Product : 6 days/period(total 3 period)
1 secondary outcome
Assessment of the bisoprolol and rosuvastatin:tmax,ss(Time to reach Cmax,ss), t1/2, Cmin,ss(Minimum steady-state plasma drug concentration during a dosage interval ), CL/Fss(Oral Clearance), Vd/Fss(Apparent Volume of Distribution)
Time frame: 6 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Jae-wook Ko, phD principal investigator
Samsung Medical Conter
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab and Concor 5mg 2T and Crestor 20 mg 1Tab 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 5 inclusion and 14 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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 bisoprolol and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve) (time frame: 6 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.