Arterial Hypertension (PAH)Phase 1NCT07694128
Bioequivalence Study to Compare Selexipag 400 Microgram Film Coated Tablets Versus Uptravi® (Selexipag) 400 Microgram Film Coated Tablets
A Phase 1 study testing Selexipag Film Coated Tablets (T1), Selexipag Film Coated Tablets (T2) and Uptravi® (selexipag) film coated tablets in people with Arterial Hypertension (PAH), run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial summary
An open label, randomized, Three treatment, Three sequence, Three period, Three way crossover, single dose oral bioequivalence study to compare Selexipag 400 microgram film coated tablets versus Uptravi® (selexipag) 400 microgram film coated tablets in fed condition. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Hypertension (PAH)
- What is being tested?
- Selexipag Film Coated Tablets (T1), Selexipag Film Coated Tablets (T2) and Uptravi® (selexipag) 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
- 8 Apr 2026to 22 Jun 2026
- 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
- Participants aged between 18 to 55 years (both inclusive).
- Participants' weight within normal range according to normal values for Body Mass Index (between 18.50 to 30.00 kg/m2) (both inclusive) with minimum of 45 kg weight.
- Participants with normal health as determined by personal medical history, clinical examination and laboratory examinations within Predefined site Normal range [Annexure III].
- Participants having clinically acceptable 12-lead electrocardiogram (ECG).
- Participants having clinically acceptable chest X-Ray (PA view), if taken.
- Participants having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
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- Participants having negative urine alcohol test / breath alcohol test.
- Non-smoker.
- Participants willing to adhere to the protocol requirements and to provide written informed consent.
- For Male Participants: Participants willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence. Participants willing to refrain from donating sperm during the study period
- For Female Participants: Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as intrauterine device (IUD), abstinence, bilateral tubal ligation or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam or Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above
- Participants having negative urine pregnancy test at screening and negative serum beta-hCG pregnancy test on admission day of period 01 (only for female Participants).
Who cannot join
- Hypersensitivity to Selexipag or ondansetron, paracetamol, or related class of drugs or any of its excipients.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01.
- Presence of alcoholism or drug abuse.
- History or presence of asthma, urticaria or other significant allergic reactions.
- History or presence of significant gastric and/or duodenal ulceration.
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- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- History or presence of serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including SSRIs and SNRIs).
- History or presence of cancer or basal or squamous cell carcinoma.
- Difficulty with donating blood.
- Difficulty in swallowing solids dosage form like tablets or capsules.
- Use of any prescribed medication or OTC medication including vaccines, vitamins and herbal remedies during last 30 days prior to admission in period 01.
- Major illness within past 3 months.
- Participant who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
- Consumption of xanthine-containing foods or beverages (like chocolate, tea, coffee or cola drinks), tobacco containing products or alcohol or any alcohol containing products within 48.00 hours prior to admission in period 01.
- Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission of period 01.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
- Participants who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- Female Participants who are currently breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Single Dose, Three Treatment, Three Sequence, Three Period, Three Way Crossover Oral Bioequivalence Study to Compare Selexipag 400 Microgram Film Coated Tablets Versus Uptravi® (Selexipag) 400 Microgram Film Coated Tablets in Fed Condition.
An open label, randomized, Three treatment, Three sequence, Three period, Three way crossover, single dose oral bioequivalence study to compare Selexipag 400 microgram film coated tablets versus Uptravi® (selexipag) 400 microgram film coated tablets in fed condition.
- Conditions
- Arterial Hypertension (PAH)
- Being tested
- Selexipag Film Coated Tablets (T1), Selexipag Film Coated Tablets (T2), Uptravi® (selexipag) film coated tablets
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selexipag Film Coated Tablets (T1)Drug
1 tablet of Selexipag 400 microgram film coated tablets
Selexipag Film Coated Tablets (T2)Drug
1 tablet of Selexipag 400 microgram film coated tablets
Uptravi® (selexipag) film coated tabletsDrug
1 tablet of Uptravi® (selexipag) 400 microgram film coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Selexipag film coated tablets (T1) | Experimental | Selexipag 400 microgram film coated tablets Receives: Drug: Selexipag Film Coated Tablets (T1); Drug: Selexipag Film Coated Tablets (T2); Drug: Uptravi® (selexipag) film coated tablets |
| Selexipag film coated tablets (T2) | Experimental | Selexipag 400 microgram film coated tablets Receives: Drug: Selexipag Film Coated Tablets (T1); Drug: Selexipag Film Coated Tablets (T2); Drug: Uptravi® (selexipag) film coated tablets |
| Uptravi® (selexipag) film coated tablets | Active comparator | Uptravi® (selexipag) 400 microgram film coated tablets Receives: Drug: Selexipag Film Coated Tablets (T1); Drug: Selexipag Film Coated Tablets (T2); Drug: Uptravi® (selexipag) 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-sides 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: 20 hours
AUC from time 0 to last collection time (AUC0 - t)
two-sides 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 AUC
Measured: 20 hours
Secondary outcomes (2)
Time to reach maximum concentration Cmax (Tmax)
Descriptive Statistics
Measured: 20 hours
Area Under the Curve from time zero to time infinite (AUC0-infinite)
Descriptive Statistics
Measured: 20 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start8 Apr 2026
- Primary completion16 Jun 2026
- Study completion22 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Hypertension (PAH)Studies 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
- NCT07694128
- Sponsor's protocol ID
- 25-VIN-0711
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Single Dose, Three Treatment, Three Sequence, Three Period, Three Way Crossover Oral Bioequivalence Study to Compare Selexipag 400 Microgram Film Coated Tablets Versus Uptravi® (Selexipag) 400 Microgram Film Coated Tablets in Fed Condition.
- ClinicalTrials.gov ID
- NCT07694128
- Acronym / sponsor ID
- 25-VIN-0711
- Conditions
- Arterial Hypertension (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
- 8 Apr 2026 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 9 Jul 2026 (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.
An open label, randomized, Three treatment, Three sequence, Three period, Three way crossover, single dose oral bioequivalence study to compare Selexipag 400 microgram film coated tablets versus Uptravi® (selexipag) 400 microgram film coated tablets in fed condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Selexipag film coated tablets (T1) | Experimental | Drug: Selexipag Film Coated Tablets (T1), Drug: Selexipag Film Coated Tablets (T2), Drug: Uptravi® (selexipag) film coated tabletsSelexipag 400 microgram film coated tablets |
| Selexipag film coated tablets (T2) | Experimental | Drug: Selexipag Film Coated Tablets (T1), Drug: Selexipag Film Coated Tablets (T2), Drug: Uptravi® (selexipag) film coated tabletsSelexipag 400 microgram film coated tablets |
| Uptravi® (selexipag) film coated tablets | Active comparator | Drug: Selexipag Film Coated Tablets (T1), Drug: Selexipag Film Coated Tablets (T2), Drug: Uptravi® (selexipag) film coated tabletsUptravi® (selexipag) 400 microgram film coated tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Participants aged between 18 to 55 years (both inclusive).
- Participants' weight within normal range according to normal values for Body Mass Index (between 18.50 to 30.00 kg/m2) (both inclusive) with minimum of 45 kg weight.
- Participants with normal health as determined by personal medical history, clinical examination and laboratory examinations within Predefined site Normal range [Annexure III].
- Participants having clinically acceptable 12-lead electrocardiogram (ECG).
- Participants having clinically acceptable chest X-Ray (PA view), if taken.
Key exclusion criteria (21 listed)
- Hypersensitivity to Selexipag or ondansetron, paracetamol, or related class of drugs or any of its excipients.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01.
- Presence of alcoholism or drug abuse.
- History or presence of asthma, urticaria or other significant allergic reactions.
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 |
|---|---|---|
| Selexipag Film Coated Tablets (T1)1 tablet of Selexipag 400 microgram film coated tablets | Drug | Selexipag film coated tablets (T1), Selexipag film coated tablets (T2), Uptravi® (selexipag) film coated tablets |
| Selexipag Film Coated Tablets (T2)1 tablet of Selexipag 400 microgram film coated tablets | Drug | Selexipag film coated tablets (T1), Selexipag film coated tablets (T2), Uptravi® (selexipag) film coated tablets |
| Uptravi® (selexipag) film coated tablets1 tablet of Uptravi® (selexipag) 400 microgram film coated tablets | Drug | Selexipag film coated tablets (T1), Selexipag film coated tablets (T2), Uptravi® (selexipag) film coated tablets |
Primary outcome
Maximum concentration obtained (Cmax)
Time frame: 20 hours
two-sides 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 (AUC0 - t)
Time frame: 20 hours
two-sides 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 AUC
2 secondary outcomes
Time to reach maximum concentration Cmax (Tmax)
Time frame: 20 hours
Area Under the Curve from time zero to time infinite (AUC0-infinite)
Time frame: 20 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 9 Jul 2026.
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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 Selexipag Film Coated Tablets (T1), Selexipag Film Coated Tablets (T2) and Uptravi® (selexipag) film coated tablets in people with Arterial Hypertension (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 12 inclusion and 21 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 9 Jul 2026. 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: 20 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 9 Jul 2026.