Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus U⦠(NCT06932198) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus UptraviĀ® 400mcg Film Coated Tablets (400 mcg Selexipag)
Jordan14 participantsStarted 2025-01-09
Plain-language 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 UptraviĀ® 400mcg Film Coated Tablets (400 mcg Selexipag), in healthy subjects under fed conditions.
Who can participate
Age range18 Years ā 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
* The subject Haematology teā¦
What they're measuring
1
Maximum concentration (Cmax)
Timeframe: 72 hours
2
AUC from time 0 to last collection time t (AUC0 - t)