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Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag)

Randomized, Single Oral Dose, Two-period, Two-treatment, Two-sequence Open-label, Crossover, Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag), in Healthy Subjects Under Fed Conditions

NCT06932198•Humanis Saglık Anonim Sirketi

View on ClinicalTrials.gov

Summary

Randomized, single oral dose, two-period, two-treatment, two-sequence open-label, crossover, bioequivalence study to compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag), in healthy subjects under fed conditions.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•The subject is Caucasian \& aged between eighteen to fifty (18-50), both inclusive.
•The subject is within the limits for his/her 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.
•The subject is able to understand and willing to sign the informed consent form.
•For female subjects: negative serum pregnancy test and the married woman is using two reliable contraception methods and should be non-lactating.
•The subject has normal cardiovascular system \& normal ECG with normal QT interval corrected for heart rate according to Bazett's formula.
•The subject kidney and liver (AST \& ALT enzymes) functions tests are within normal range. (Creatinine is accepted if below the reference range after being evaluated by the clinical investigator as clinically not significant).
+3 more criteria

Exclusion Criteria

•The subject is a heavy smoker (more than 10 cigarettes per day).
•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 suffered an acute illness one week before dosing.
•The subject has been hospitalized within three months before the study or during the study.
•The subject is on special diet (for example subject is vegetarian.)
•The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 72 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/orange containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
+6 more criteria

Locations (1)

ACDIMA Center

Amman, Jordan

Key Dates

Start Date

January 9, 2025

Primary Completion Date

March 3, 2025

Completion Date

March 25, 2025

Last Updated

April 22, 2025

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension (PAH)

Interventions

Selexipag Film Coated Tablets

DRUG

Uptravi® Film Coated Tablets

DRUG

COMPERA / COMPERA-KIDS

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag)

Inclusion Criteria

Exclusion Criteria

COMPERA / COMPERA-KIDS

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