Cardiovascular DiseasesPhase 3NCT03485482
Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers
A Phase 3 study testing Bisoprolol, Ivabradine and combination of Ivabradine and bisoprolol in people with Cardiovascular Diseases, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of the study was to investigate the potential interaction between ivabradine and bisoprolol in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Bisoprolol, Ivabradine and combination of Ivabradine and bisoprolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 23 Mar 2018
- Phase
- Phase 3
- 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 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects should be healthy adult volunteers with age between (18-45 years) with normal body weight. Subjects should understand the procedures and are willing to participate and gave their final written consent prior to the commencement of the study procedures. The volunteers will be asked to provide a complete medical history, and complete a physical examination, laboratory tests [hematology, clinical chemistry, urinalysis, serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihuman immunodeficiency virus antibody).
Who cannot join
- Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
- Subjects who have taken any medication less than two weeks of the trials starting date.
- Susceptibility to allergic reactions to study drugs.
- Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- Gastrointestinal diseases.
- Renal diseases.
Show all 12Show fewer
- Cardiovascular diseases.
- Pancreatic disease including diabetes.
- Hepatic diseases.
- Hematological disease or pulmonary disease
- Abnormal laboratory values.
- Subjects who have donated blood or who have been involved in multiple dosing study requiring a large volume of blood (more than 500 ml) to be drawn within 6 weeks preceding the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers: An Open-Label, Randomized, Crossover Clinical Study
The purpose of the study was to investigate the potential interaction between ivabradine and bisoprolol in healthy subjects.
Read the detailed description
The aim of this study is to undergo a pharmacokinetic study to investigate the incidence of potential pharmacokinetic interaction between Ivabradine and Bisoprolol through the Assessment of the drug-drug interactions of Ivabradine and Bisoprolol by determination of pharmacokinetic parameters of both drugs administered alone and in combination. The pharmacokinetic parameters will include; The maximum plasma concentration (Cmax),the time to reach the peak concentration (tmax), area under the concentration-time curve (AUC0-t) and (AUC0-∞) during the treatment periods, the absorption and elimination rate constants (ka and kel), the half-life and mean residence time (MRT).
Study design A comparative randomized open-label three-period crossover study of ivabradine/ bisoprolol in male healthy human volunteers
Methodology
Eighteen healthy volunteer will be recruited in the study and will be divided into three groups each consisting of six volunteers as follows:
Period I:
- Group A: Six Volunteers will receive single 10 mg oral dose of ivabradin (Procoralan®, Les Laboratoires Servier Industrie-France).
- Group B: Six Volunteers will receive single oral dose of bisoprolol 5mg (Concor®).
- Group C: Six Volunteers will receive a single dose of ivabradine 10 mg and bisoprolol 5 mg
Period II:
- Group A: Six Volunteers will receive a single dose of ivabradine 10 mg and bisoprolol 5 mg
- Group B: Six Volunteers will receive single 10 mg oral dose of ivabradin.
- Group C: Six Volunteers will receive single oral dose of bisoprolol 5mg.
Period III:
- Group A: Six Volunteers will receive single oral dose of bisoprolol 5mg.
- Group B: Six Volunteers will receive a single dose of ivabradine 10 mg and bisoprolol 5 mg
- Group C: Six Volunteers will receive single 10 mg oral dose of ivabradin
All drug administration will be followed by 240 ml of water after at least 10 h fasting prior to administration. The three treatment periods will be separated by a one week washout period. Standardized meals will be served at 2, 5, and 10 h after drug dosing. All subjects should abstain from the consumption of fruit juices during the study period.
Subject Selection Criteria Eighteen adult male volunteers will be enrolled. Subjects should understand the procedures and are willing to participate and give their final written consent prior to the commencement of the study procedures.
- Conditions
- Cardiovascular Diseases
- Being tested
- Bisoprolol, Ivabradine, combination of Ivabradine and bisoprolol
- Keywords
- Pharmacokinetic drug interaction, ivabtadine, bisoprolol
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisoprololDrug
Also called Concor
bisoprolo 5 mg tablets
IvabradineDrug
Also called Procorloan
Ivabradine 10 mg tablet
combination of Ivabradine and bisoprololDrug
Also called concor plus procorolan
combination of 10 mg ivabradine and 5 mg bisoprolol
| Study group | Role | What they receive |
|---|---|---|
| Group Ivabradine | Experimental | six healthy volunteers will administer Ivabradin tablet only once single 10 mg oral dose Receives: Drug: Ivabradine |
| Group Bisoprolol | Experimental | six healthy volunteers will administer bisoprolol tablet only once single oral dose of 5mg Receives: Drug: Bisoprolol |
| Group combination | Experimental | six healthy volunteers will administer only once a combination of a single dose of ivabradine 10 mg and bisoprolol 5 mg Receives: Drug: combination of Ivabradine and bisoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
AUC0→∞
Measured: 48 hours
Pharmacokinetic parameters
AUC0→t
Measured: 48 hours
Bioavailability parameters
Cmax
Measured: 48 hours
Bioavailability parameters
t max
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Mar 2018
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- open label, randomized, single-dose, three-period, crossover design
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mahmoud Shaheen, Ain Shams University
- Investigators
- Sara Shaheen, Ass. Prof, Principal investigator, Faculty of pharamacy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485482
- Sponsor's protocol ID
- PHCL36
- Status last verified
- Mar 2018
- First submitted
- 24 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers: An Open-Label, Randomized, Crossover Clinical Study
- ClinicalTrials.gov ID
- NCT03485482
- Acronym / sponsor ID
- PHCL36
- Conditions
- Cardiovascular Diseases
- Keywords
- Pharmacokinetic drug interaction, ivabtadine, bisoprolol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 2 Apr 2018 (actual)
- 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 was to investigate the potential interaction between ivabradine and bisoprolol in healthy subjects.
Detailed description
The aim of this study is to undergo a pharmacokinetic study to investigate the incidence of potential pharmacokinetic interaction between Ivabradine and Bisoprolol through the Assessment of the drug-drug interactions of Ivabradine and Bisoprolol by determination of pharmacokinetic parameters of both drugs administered alone and in combination. The pharmacokinetic parameters will include; The maximum plasma concentration (Cmax),the time to reach the peak concentration (tmax), area under the concentration-time curve (AUC0-t) and (AUC0-∞) during the treatment periods, the absorption and elimination rate constants (ka and kel), the half-life and mean residence time (MRT).
Study design A comparative randomized open-label three-period crossover study of ivabradine/ bisoprolol in male healthy human volunteers
Methodology
Eighteen healthy volunteer will be recruited in the study and will be divided into three groups each consisting of six volunteers as follows:
Period I:
- Group A: Six Volunteers will receive single 10 mg oral dose of ivabradin (Procoralan®, Les Laboratoires Servier Industrie-France).
- Group B: Six Volunteers will receive single oral dose of bisoprolol 5mg (Concor®).
- Group C: Six Volunteers will receive a single dose of ivabradine 10 mg and bisoprolol 5 mg
Period II:
- Group A: Six Volunteers will receive a single dose of ivabradine 10 mg and bisoprolol 5 mg
- Group B: Six Volunteers will receive single 10 mg oral dose of ivabradin.
- Group C: Six Volunteers will receive single oral dose of bisoprolol 5mg.
Period III:
- Group A: Six Volunteers will receive single oral dose of bisoprolol 5mg.
- Group B: Six Volunteers will receive a single dose of ivabradine 10 mg and bisoprolol 5 mg
- Group C: Six Volunteers will receive single 10 mg oral dose of ivabradin
All drug administration will be followed by 240 ml of water after at least 10 h fasting prior to administration. The three treatment periods will be separated by a one week washout period. Standardized meals will be served at 2, 5, and 10 h after drug dosing. All subjects should abstain from the consumption of fruit juices during the study period.
Subject Selection Criteria Eighteen adult male volunteers will be enrolled. Subjects should understand the procedures and are willing to participate and give their final written consent prior to the commencement of the study procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- open label, randomized, single-dose, three-period, crossover design
| Arm | Type | Receives |
|---|---|---|
| Group Ivabradine | Experimental | Drug: Ivabradinesix healthy volunteers will administer Ivabradin tablet only once single 10 mg oral dose |
| Group Bisoprolol | Experimental | Drug: Bisoprololsix healthy volunteers will administer bisoprolol tablet only once single oral dose of 5mg |
| Group combination | Experimental | Drug: combination of Ivabradine and bisoprololsix healthy volunteers will administer only once a combination of a single dose of ivabradine 10 mg and bisoprolol 5 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects should be healthy adult volunteers with age between (18-45 years) with normal body weight. Subjects should understand the procedures and are willing to participate and gave their final written consent prior to the commencement of the study procedures. The volunteers will be asked to provide a complete medical history, and complete a physical examination, laboratory tests [hematology, clinical chemistry, urinalysis, serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihuman immunodeficiency virus antibody).
Key exclusion criteria (12 listed)
- Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
- Subjects who have taken any medication less than two weeks of the trials starting date.
- Susceptibility to allergic reactions to study drugs.
- Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- Gastrointestinal diseases.
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 |
|---|---|---|
| BisoprololAlso: Concorbisoprolo 5 mg tablets | Drug | Group Bisoprolol |
| IvabradineAlso: ProcorloanIvabradine 10 mg tablet | Drug | Group Ivabradine |
| combination of Ivabradine and bisoprololAlso: concor plus procorolancombination of 10 mg ivabradine and 5 mg bisoprolol | Drug | Group combination |
Primary outcome
Pharmacokinetic parameters
Time frame: 48 hours
AUC0→∞
Pharmacokinetic parameters
Time frame: 48 hours
AUC0→t
Bioavailability parameters
Time frame: 48 hours
Cmax
Bioavailability parameters
Time frame: 48 hours
t max
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 2 Apr 2018.
- 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.
Sara Shaheen, Ass. Prof principal investigator
Faculty of pharamacy, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bisoprolol, Ivabradine and combination of Ivabradine and bisoprolol in people with Cardiovascular Diseases, run by Ain Shams University at 1 site in Egypt.
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 1 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 2 Apr 2018. 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 Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pharmacokinetic parameters (time frame: 48 hours). The study lists 4 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 2 Apr 2018.