Trials Sponsors Conditions Drugs Pricing

Conditions

Arterial Hypertension (PAH)

Outcome Measures

Primary Outcomes (2)

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
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
20 hours

Secondary Outcomes (2)

Time to reach maximum concentration Cmax (Tmax)
20 hours
Area Under the Curve from time zero to time infinite (AUC0-infinite)
20 hours

Study Arms (3)

Selexipag film coated tablets (T1)

EXPERIMENTAL

Selexipag 400 microgram film coated tablets

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

Drug: Selexipag Film Coated Tablets (T1)Drug: Selexipag Film Coated Tablets (T2)Drug: Uptravi® (selexipag) film coated tablets

Interventions

Selexipag Film Coated Tablets (T1)Drug

1 tablet of Selexipag 400 microgram film coated tablets

Selexipag film coated tablets (T1)Selexipag film coated tablets (T2)Uptravi® (selexipag) film coated tablets

Selexipag Film Coated Tablets (T2)Drug

1 tablet of Selexipag 400 microgram film coated tablets

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Humanis Saglık Anonim Sirketi
Industrylead

Study Sites (1)

Veeda Clinical Research Ltd.

Ahmedabad, Gujarat, 380 015, India

MeSH Terms

Conditions

Hypertension

Interventions

selexipag

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 9, 2026

Study Start

April 8, 2026

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (3)

Selexipag film coated tablets (T1)

Selexipag film coated tablets (T2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Uptravi® (selexipag) film coated tablets

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (3)

Selexipag film coated tablets (T1)

Selexipag film coated tablets (T2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Uptravi® (selexipag) film coated tablets

You may not qualify if:

Source record

Locations