Healthy Clinical Trial
Official title:
A Single-Dose, Open Label, Randomized, Two-Way Crossover Pharmacokinetic Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Following Intake of Tablet Versus Capsule in Healthy Subjects
The purpose of this study is to evaluate the relative bioavailability of JNJ-42756493 oral dose of capsule (reference) versus tablet (test) in healthy participants.
This is a Phase 1, randomized (study drug assigned by chance), open-label (all people know the identity of the intervention), 2 way crossover (method used to switch participants from one study group change to treatment group), single-dose study in healthy participants. The study will consist of 3 phases: Screening Phase (Day -21 to Day -2), Treatment Phase (consists of 2 single-dose treatment period, either JNJ-42756493 capsule or JNJ-42756493 tablet) and Follow-up Phase (12-14 days after last dose). All the eligible participants will be randomly assigned to 1 of the 2 treatment sequences to ensure that they receive both of the treatments, 1 in each period. Each treatment regimen will be separated by a washout period of at least 15 days. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of two dosage form of JNJ-42756493 (test and reference) will be evaluated primarily. Participants' safety will be monitored throughout the study. ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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