drugset / Trial / NCT02561936

Relative Bioavailability of Three Oral Formulations Candidates of Rilpivirine for Potential Pediatric Use Compared to Oral Tablet

NCT02561936

Phase 1 Completed 32 enrolled Janssen Sciences Ireland UC
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to compare the rate and extent of absorption of rilpivirine in healthy adult participants following: 1) administration of a single dose of two different oral dispersible tablet formulation candidates and of an oral granules formulation with that following administration of a single dose of the 25-milligram (mg) oral tablet (EDURANT), after a standardized breakfast; 2) administration of a single dose of one selected oral formulation candidate (a dispersible tablet or granules) in different fed conditions (standardized breakfast or yoghurt) and in the fasted state and breakfast and 3) administration of a single dose of one selected oral formulation candidate (a dispersible tablet or granules) dispersed in water or in orange juice, in fed condition (standardized breakfast).

Timeline

Start
2015-10
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilpivirine Small molecule 25 mg Oral

Indications

No indication recorded.