PAHPhase 1NCT06553937
Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg
A Phase 1 study testing Macitentan and Tadalafil and PrOpsynvi® Film-Coated Tablets in people with PAH, run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial summary
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- PAH
- What is being tested?
- Macitentan and Tadalafil and PrOpsynvi® Film-Coated Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 10 May 2024to 31 Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified.
- 1) Age: 18 to 55 years old, both inclusive. 2) Gender: Male. 3) BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5). 4) Non-smokers and non-tobacco users (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study).
- 5) Able to communicate effectively with study personnel. 6) Willing to provide written informed consent to participate in the study. 7) All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include:
- A physical examination (clinical examination) with no clinically significant finding.
- Results within normal limits or clinically non-significant for the following tests: Hematology Hemoglobin Total RBC count Total WBC count Platelet count
- Differential leukocyte count:
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- Neutrophils Lymphocytes Eosinophils Monocytes Basophils Blood indices: HCT Biochemistry BUN, Serum creatinine, Random glucose, SGPT \& SGOT Alkaline phosphatase Uric acid Serum bilirubin Serum total protein: Total proteins, Albumin Serum electrolytes: Serum sodium, serum chloride, serum potassium, serum phosphorous, serum calcium Urinalysis Color, quantity, specific gravity, odour, appearance, reaction, albumin, bilirubin, ketone bodies, sugar, urobilinogen and microscopical examination (performed based on clinical judgment) Immunological Tests HIV-I \& II, HbsAg ,Anti HCV
- Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion.
- All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.
Who cannot join
- Volunteers must not be enrolled in the study if they meet any one of the following criteria:
- 1) History of allergic responses to Macitentan, Tadalafil or other related drugs, or any of its formulation ingredients.
- Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording].
- 3) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- 4) History or presence of bronchial asthma. 5) Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
- 6) Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
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- 7) Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug interactions.medicine.iu.edu/MainTable.aspx). 8) History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- 9) History of difficulty with donating blood or difficulty in accessibility of veins.
- 10) A positive hepatitis screen (includes subtypes B \& C). 11) A positive test result for HIV antibody. 12) Volunteers who have received an investigational drug within 90 days prior to the first dose of study medication.
- 13) Volunteers who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
- 14) History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
- 15) Intolerance to venipuncture 16) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study.
- 17) Institutionalized volunteers. 18) Use of any prescribed medications [Including guanylate cyclase stimulators, such as riociguat and potent CYP3A4 inhibitors (e.g. ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin)] within 14 days prior to the first dose of study medication.
- 19) Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
- 20) Use of grapefruit and grapefruit containing products within 7 days prior to the first döşe of study medication.
- Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), recreational drugs, alcohol or other alcohol containing products, dietary items that have effect on P450 enzymes (e.g. pomegranate, star fruit, seville oranges) \& PGP (P-Glycoprotein) efflux pump (e.g. St. John's wort) within 48 hours prior to the first dose of study medication.
- 22) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
- 23) Use of any form of organic nitrate. 24) History of myocardial infarction, unstable angina or angina, heart failure, uncontrolled arrhythmias, hypotension, uncontrolled hypertension or stroke.
- 25) Presence of anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease).
- 26) History or presence of benign prostatic hyperplasia. 27) History of vision loss or optic neuropathy. 28) Volunteer having Hemoglobin value lower than the lower limit of normal range during screening.
- 29) SGPT, SGOT and alkaline phosphatase values 1.1 times higher than the upper limit of normal range during screening.
- 30) Serum bilirubin value higher than the upper limit of normal range during screening.
- 31) History of heart failure, pulmonary edema, fluid retention/peripheral edema, or chronic liver disease.
- 32) History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Oral Bioequivalence Study of Macitentan and Tadalafil Filmcoated Tablets 10 Mg/40 Mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg in Healthy Adult Male Subjects Under Fed Conditions
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fed conditions.
- Conditions
- PAH
- Being tested
- Macitentan and Tadalafil, PrOpsynvi® Film-Coated Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macitentan and TadalafilDrug
1 tablet of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg
PrOpsynvi® Film-Coated TabletsDrug
1 tablet of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg
| Study group | Role | What they receive |
|---|---|---|
| Macitentan and Tadalafil | Experimental | Macitentan and Tadalafil film-coated tablets 10 mg/40 mg Receives: Drug: Macitentan and Tadalafil; Drug: PrOpsynvi® Film-Coated Tablets |
| PrOpsynvi® film-coated tablets | Active comparator | PrOpsynvi® film-coated tablets10 mg/40 mg Receives: Drug: Macitentan and Tadalafil; Drug: PrOpsynvi® Film-Coated Tablets |
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 - 125.00% for each of the Ln-transformed data Cmax
Measured: 72 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 - 125.00% for each of the Ln-transformed data AUC0-t
Measured: 72 hours
Secondary outcomes (2)
AUC from time 0 to infinity (AUCt-∞)
Descriptive Statistics
Measured: 72 hours
Time to reach maximum concentration Cmax (Tmax)
Descriptive Statistics
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start10 May 2024
- Primary completion3 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAHStudies 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
- 30 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
- NCT06553937
- Sponsor's protocol ID
- C1B03967
- Status last verified
- Sep 2024
- First submitted
- 12 Aug 2024
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Oral Bioequivalence Study of Macitentan and Tadalafil Filmcoated Tablets 10 Mg/40 Mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg in Healthy Adult Male Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT06553937
- Acronym / sponsor ID
- C1B03967
- Conditions
- PAH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 10 May 2024 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Aug 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.
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fed conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macitentan and Tadalafil | Experimental | Drug: Macitentan and Tadalafil, Drug: PrOpsynvi® Film-Coated TabletsMacitentan and Tadalafil film-coated tablets 10 mg/40 mg |
| PrOpsynvi® film-coated tablets | Active comparator | Drug: Macitentan and Tadalafil, Drug: PrOpsynvi® Film-Coated TabletsPrOpsynvi® film-coated tablets10 mg/40 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Volunteers must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified.
- 1) Age: 18 to 55 years old, both inclusive. 2) Gender: Male. 3) BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5). 4) Non-smokers and non-tobacco users (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study).
- 5) Able to communicate effectively with study personnel. 6) Willing to provide written informed consent to participate in the study. 7) All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include:
- A physical examination (clinical examination) with no clinically significant finding.
- Results within normal limits or clinically non-significant for the following tests: Hematology Hemoglobin Total RBC count Total WBC count Platelet count
Key exclusion criteria (24 listed)
- Volunteers must not be enrolled in the study if they meet any one of the following criteria:
- 1) History of allergic responses to Macitentan, Tadalafil or other related drugs, or any of its formulation ingredients.
- Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording].
- 3) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- 4) History or presence of bronchial asthma. 5) Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
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 |
|---|---|---|
| Macitentan and Tadalafil1 tablet of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg | Drug | Macitentan and Tadalafil, PrOpsynvi® film-coated tablets |
| PrOpsynvi® Film-Coated Tablets1 tablet of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg | Drug | Macitentan and Tadalafil, PrOpsynvi® film-coated tablets |
Primary outcome
Maximum concentration obtained (Cmax)
Time frame: 72 hours
two-sided 90% CI for the test to reference ratio of the population means is within 80.00 - 125.00% for each of the Ln-transformed data Cmax
AUC from time 0 to last collection time t (AUC0-t)
Time frame: 72 hours
two-sided 90% CI for the test to reference ratio of the population means is within 80.00 - 125.00% for each of the Ln-transformed data AUC0-t
2 secondary outcomes
AUC from time 0 to infinity (AUCt-∞)
Time frame: 72 hours
Time to reach maximum concentration Cmax (Tmax)
Time frame: 72 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 19 Sep 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 Macitentan and Tadalafil and PrOpsynvi® Film-Coated Tablets in people with PAH, run by Humanis Saglık Anonim Sirketi at 1 site in India.
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 9 inclusion and 24 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 19 Sep 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 India. 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: 72 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 19 Sep 2024.