BioequivalencePhase 1NCT04101370
Bioequivalence Study of Bosentan 125 mg Tablets Immediate Release (IR) Versus Tracleer® 125 mg Tablets IR In Healthy Subjects
A Phase 1 study testing Bosentan 125 mg and Tracleer 125Mg Tablet in people with Bioequivalence, run by Geropharm at 1 site in Russia.
Trial summary
Bioequivalence Study of 2 formulation of bosentan (Bosentan GEROPHARM vers. Tracleer® Actelion) Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Bosentan 125 mg and Tracleer 125Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteRussia
- Study dates
- 24 May 2018to 20 Jun 2018
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent form.
- Healthy male aged 18 to 45 years.
- Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
- Have a body mass index between 18,5 and 30 kg/m2.
- Subjects must use, with their partner, methods of highly effective contraception throughout the study and 30 days after the end of study.
- Ability to keep fasting state for at least 14 hours.
- Consent and ability to respect the schedule of visits and the points of the Protocol.
Who cannot join
- History of serious allergic problems/events.
- Medicinal intolerance.
- Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- Psychiatric disorders, history of epilepsy and seizures.
- Acute infectious diseases in less than 4 weeks before the start of the study.
- Subjects who have taken medication 2 weeks preceding before the study.
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- Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).
- Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.
- History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
- Smokers.
- Participation in other clinical training is less than than for 3 months before the study.
- Lack of signed informed consent form.
- 10% deviation from references in lab tests.
- Positive testing for alcohol, drugs.
- Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.
- Any diet (vegetarian, etc.) extreme physical exercise, night shift work.
- Heart rate below 60 or above 80 beats per minute.
- Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg.
- Diastolic blood pressure less than 60 mm Hg or more than 89 mm Hg.
- Volunteers, for Investigator opinion, who can not understand and evaluate the information about this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-way Crossover, Open-label, Single-dose, Bioequivalence Study of Bosentan (LLC "GEROPHARM", Russia) 125 mg Tablets Immediate Release (IR )Versus Tracleer® (Actelion Pharmaceuticals Ltd., Switzerland) 125 mg Tablets IR in Normal Healthy Subjects Under Fasting Conditions
Bioequivalence Study of 2 formulation of bosentan (Bosentan GEROPHARM vers. Tracleer® Actelion)
Read the detailed description
Study to evaluate the bioequivalence of orally administered bosentan preparations, immediate release tablets, 125 mg in normal healthy subjects under fasting conditions
- Conditions
- Bioequivalence
- Being tested
- Bosentan 125 mg, Tracleer 125Mg Tablet
- Keywords
- AUC, Cmax, Pharmacokinetics, bosentan, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bosentan 125 mgDrug
Also called bosentan
Single administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition
Tracleer 125Mg TabletDrug
Also called bosentan
Single administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition
| Study group | Role | What they receive |
|---|---|---|
| Bosentan | Experimental | Single administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition Receives: Drug: Bosentan 125 mg |
| Tracleer® | Active comparator | Single administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition Receives: Drug: Tracleer 125Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetics of bosentan by Assessment of Observed Maximum Plasma Concentration (Cmax)
Measured: 0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour post-dose.
AUC(0-t)
Pharmacokinetics of bosentan by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
Measured: 0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour 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 Sep 2019
- Study start24 May 2018
- Primary completion20 Jun 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment two-way crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geropharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101370
- Sponsor's protocol ID
- BOZ-501
- Status last verified
- Mar 2019
- First submitted
- 23 Sep 2019
- Last updated
- 24 Sep 2019
- 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 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-way Crossover, Open-label, Single-dose, Bioequivalence Study of Bosentan (LLC "GEROPHARM", Russia) 125 mg Tablets Immediate Release (IR )Versus Tracleer® (Actelion Pharmaceuticals Ltd., Switzerland) 125 mg Tablets IR in Normal Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04101370
- Acronym / sponsor ID
- BOZ-501
- Conditions
- Bioequivalence
- Keywords
- AUC, Cmax, Pharmacokinetics, bosentan, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- GeropharmIndustry (pharma, biotech, devices)
- Study start
- 24 May 2018 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 24 Sep 2019 (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.
Bioequivalence Study of 2 formulation of bosentan (Bosentan GEROPHARM vers. Tracleer® Actelion)
Detailed description
Study to evaluate the bioequivalence of orally administered bosentan preparations, immediate release tablets, 125 mg in normal healthy subjects under fasting conditions
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover Assignment two-way crossover
| Arm | Type | Receives |
|---|---|---|
| Bosentan | Experimental | Drug: Bosentan 125 mgSingle administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition |
| Tracleer® | Active comparator | Drug: Tracleer 125Mg TabletSingle administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent form.
- Healthy male aged 18 to 45 years.
- Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
- Have a body mass index between 18,5 and 30 kg/m2.
- Subjects must use, with their partner, methods of highly effective contraception throughout the study and 30 days after the end of study.
Key exclusion criteria (20 listed)
- History of serious allergic problems/events.
- Medicinal intolerance.
- Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- Psychiatric disorders, history of epilepsy and seizures.
- Acute infectious diseases in less than 4 weeks before the start of the study.
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 |
|---|---|---|
| Bosentan 125 mgAlso: bosentanSingle administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition | Drug | Bosentan |
| Tracleer 125Mg TabletAlso: bosentanSingle administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition | Drug | Tracleer® |
Primary outcome
Cmax
Time frame: 0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour post-dose.
Pharmacokinetics of bosentan by Assessment of Observed Maximum Plasma Concentration (Cmax)
AUC(0-t)
Time frame: 0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour post-dose.
Pharmacokinetics of bosentan by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
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 24 Sep 2019.
- 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 Bosentan 125 mg and Tracleer 125Mg Tablet in people with Bioequivalence, run by Geropharm at 1 site in Russia.
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 7 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 24 Sep 2019. 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 Russia. 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?
Cmax (time frame: 0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour 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 24 Sep 2019.