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Bioequivalence Study of Different Aprocitentan Tablet Formulations

NCT05196399 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-11-23

No results posted yet for this study

Summary

The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations.

Conditions

  • Healthy Subjects

Interventions

DRUG

Aprocitentan (Formulation A)

A single oral dose of 25 mg.

DRUG

Aprocitentan (Formulation B)

A single oral dose of 25 mg.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

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
2022-02-02
Primary Completion
2022-03-27
Completion
2022-04-07

Countries

  • Czechia

Study Locations

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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 NCT05196399 on ClinicalTrials.gov