drugset / Trial / NCT02385071

A Crossover Study to Evaluate Relative Bioavailability of Simeprevir Age-appropriate Oral Formulation Candidates Compared With 150-milligram (mg) Oral Capsule in Healthy Adult Participants

NCT02385071

Phase 1 Completed 48 enrolled Janssen Sciences Ireland UC
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to assess the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of simeprevir (SMV) following single dose administration of age-appropriate oral formulation candidates compared to the 150 milligram (mg) capsule, and to assess the effect of food on the bioavailability of SMV following single dose administration of a selected age-appropriate oral formulation candidate.

Timeline

Start
2015-04-28
Primary completion
2015-09-09
Completion
2015-09-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Simeprevir Small molecule 150 mg Oral

Indications

No indication recorded.