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Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:
Single-center, Open-label, Phase 1 Study Consisting of a Single-dose Pilot Phase and a Randomized, Two-way Crossover, Single-dose Main Phase to Investigate the Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Male Subjects

Clinical Trial Summary

The primary purpose of this phase 1 study is to investigate the absolute bio-availability of a single oral dose of selexipag, i.e., to assess the amount of selexipag which reaches the blood when administered as an oral tablet (ACT-293987) compared to an intravenous administration in healthy subjects.

Clinical Trial Description

A pilot phase was conducted in 3 male subjects before the main phase for assessment of absolute bio-availability conducted in 16 other male subjects. The pilot phase aimed to determine the intravenous dose to be used in the main phase based on safety data and pharmacokinetics data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02882425
Study type Interventional
Source Actelion
Contact
Status Completed
Phase Phase 1
Start date January 2015
Completion date April 2015
View Details
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