MedTrace Logo

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

NCT07694128 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-09

No results posted yet for this study

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.

Conditions

  • Arterial Hypertension (PAH)

Interventions

DRUG

Uptravi® (selexipag) film coated tablets

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

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

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2026-06-16
Completion
2026-06-22

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07694128 on ClinicalTrials.gov