Pulmonary Arterial HypertensionPhase 1NCT06484673
Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets
A Phase 1 study testing Bosentan Dispersible Tablets and Tracleer Tablet for Oral Suspension in people with Pulmonary Arterial Hypertension, run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.
Trial summary
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Bosentan 32 mg Dispersible Tablets versus Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan), in healthy subjects under fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Bosentan Dispersible Tablets and Tracleer Tablet for Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteJordan
- Study dates
- 21 Apr 2024to 27 May 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is male \& aged between eighteen to forty-five years (18 - 45), both inclusive.
- The subject is within the limits for his height \& weight as defined by the body mass index range (18.5 - 30.0 Kg/m2).
- The subject is willing to undergo the necessary pre- \& post- medical examinations set by this study.
- The results of medical history, physical examination, vital signs \& conducted medical laboratory tests are normal as determined by the clinical investigator.
- The subject tested negative for Hepatitis B (HBsAg), Hepatitis C (HCVAb) and human immunodeficiency virus (HIVAb).
- There is no evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
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- The subject is able to understand and willing to sign the informed consent form.
- The subject has normal cardiovascular system, pulmonary system \& ECG recording.
- The subject kidney and liver functions (AST \& ALT enzymes) tests are within normal range.
- The subject blood pressure is ≥ 110/70 mmHg before dosing.
Who cannot join
- The subject is a heavy smoker (more than 10 cigarettes per day).
- The subject has suffered an acute illness one week before dosing.
- The subject has a history of or concurrent abuse of alcohol.
- The subject has a history of or concurrent abuse of illicit drugs.
- The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
- The subject has been hospitalized within three months before the study or during the study.
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- The subject is vegetarian.
- The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 48 hours after dosing in both study periods.
- The subject has taken a prescription medication within two weeks or even an over the counter product (OTC) within one week before dosing in each study period and any time during the study, unless otherwise judged acceptable by the clinical investigator.
- The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
- The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the present study.
- The subject has donated blood within 80 days before first dosing.
- The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
- The subject has consumed any drugs that may affect pharmacological or pharmacokinetic properties of Bosentan. (for example: fluconazole, amiodarone, ketoconazole, itraconazole, amprenavir, erythromycin, fluconazole, diltiazem, Cyclosporine A, Glyburide, Norethindron, Ethinyl estradiol, Simvastatin, lopinavir, ritonavir, Rifampin) two weeks before and after the study and during the study.
- The subject suffer from phenylketonuria disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan), in Healthy Subjects Under Fasting Condition
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Bosentan 32 mg Dispersible Tablets versus Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan), in healthy subjects under fasting condition.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Bosentan Dispersible Tablets, Tracleer Tablet for Oral Suspension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bosentan Dispersible TabletsDrug
1 tablet of 32 mg Bosentan
Tracleer Tablet for Oral SuspensionDrug
1 tablet of 32 mg Bosentan
| Study group | Role | What they receive |
|---|---|---|
| Bosentan 32 mg Dispersible Tablets | Experimental | Bosentan 32 mg Dispersible Tablets Receives: Drug: Bosentan Dispersible Tablets; Drug: Tracleer Tablet for Oral Suspension |
| Tracleer® 32 mg Tablets for Oral Suspension | Active comparator | Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan) Receives: Drug: Bosentan Dispersible Tablets; Drug: Tracleer Tablet for Oral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration obtained (Cmax)
two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax
Measured: 23 hours
AUC from time 0 to last collection time t (AUC0-t)
two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data AUC0-t
Measured: 23 hours
Secondary outcomes (2)
AUC from time 0 to infinity (AUC0-inf)
Description Statistics
Measured: 23 hours
Time of the maximum measured plasma concentration (Tmax)
Description Statistics
Measured: 23 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start21 Apr 2024
- Primary completion22 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484673
- Sponsor's protocol ID
- 1293-2024
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan), in Healthy Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT06484673
- Acronym / sponsor ID
- 1293-2024
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2024 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 3 Jul 2024 (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.
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Bosentan 32 mg Dispersible Tablets versus Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan), in healthy subjects under fasting condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bosentan 32 mg Dispersible Tablets | Experimental | Drug: Bosentan Dispersible Tablets, Drug: Tracleer Tablet for Oral SuspensionBosentan 32 mg Dispersible Tablets |
| Tracleer® 32 mg Tablets for Oral Suspension | Active comparator | Drug: Bosentan Dispersible Tablets, Drug: Tracleer Tablet for Oral SuspensionTracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject is male \& aged between eighteen to forty-five years (18 - 45), both inclusive.
- The subject is within the limits for his height \& weight as defined by the body mass index range (18.5 - 30.0 Kg/m2).
- The subject is willing to undergo the necessary pre- \& post- medical examinations set by this study.
- The results of medical history, physical examination, vital signs \& conducted medical laboratory tests are normal as determined by the clinical investigator.
- The subject tested negative for Hepatitis B (HBsAg), Hepatitis C (HCVAb) and human immunodeficiency virus (HIVAb).
Key exclusion criteria (15 listed)
- The subject is a heavy smoker (more than 10 cigarettes per day).
- The subject has suffered an acute illness one week before dosing.
- The subject has a history of or concurrent abuse of alcohol.
- The subject has a history of or concurrent abuse of illicit drugs.
- The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
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 Dispersible Tablets1 tablet of 32 mg Bosentan | Drug | Bosentan 32 mg Dispersible Tablets, Tracleer® 32 mg Tablets for Oral Suspension |
| Tracleer Tablet for Oral Suspension1 tablet of 32 mg Bosentan | Drug | Bosentan 32 mg Dispersible Tablets, Tracleer® 32 mg Tablets for Oral Suspension |
Primary outcome
Maximum concentration obtained (Cmax)
Time frame: 23 hours
two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax
AUC from time 0 to last collection time t (AUC0-t)
Time frame: 23 hours
two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data AUC0-t
2 secondary outcomes
AUC from time 0 to infinity (AUC0-inf)
Time frame: 23 hours
Time of the maximum measured plasma concentration (Tmax)
Time frame: 23 hours
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 3 Jul 2024.
- 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 Dispersible Tablets and Tracleer Tablet for Oral Suspension in people with Pulmonary Arterial Hypertension, run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.
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 10 inclusion and 15 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 3 Jul 2024. 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 Jordan. 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?
Maximum concentration obtained (Cmax) (time frame: 23 hours). 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 3 Jul 2024.