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COMPLETED
NCT07694128
PHASE1

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

Sponsor: Humanis Saglık Anonim Sirketi

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-04-08

Completion Date

2026-06-22

Last Updated

2026-07-09

Healthy Volunteers

Yes

Interventions

DRUG

Selexipag Film Coated Tablets (T1)

1 tablet of Selexipag 400 microgram film coated tablets

DRUG

Selexipag Film Coated Tablets (T2)

1 tablet of Selexipag 400 microgram film coated tablets

DRUG

Uptravi® (selexipag) film coated tablets

1 tablet of Uptravi® (selexipag) 400 microgram film coated tablets

Locations (1)

Veeda Clinical Research Ltd.

Ahmedabad, Gujarat, India