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A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-63623872/Oseltamivir Fixed-dose Combination Tablet and Single Agent Concept Formulations of JNJ-63623872 Compared to Their Respective Reference Formulation in Healthy Adult Participants

NCT03023852 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-05-25

No results posted yet for this study

Summary

The purpose of this study is to assess the rate and extent of absorption of JNJ63623872 following administration of a single oral dose of 2\*300 milligram (mg) given as 2 concept single agent tablet formulations compared to the administration of 2\*300 mg JNJ63623872 reference tablets, under fasted conditions in healthy adult participants and to assess the rate and extent of absorption of JNJ63623872 and oseltamivir following administration of a single oral dose of 2\*300 mg/37.5 mg JNJ63623872/ oseltamivir given as a concept fixed dose combination (FDC) tablet formulation compared to the coadministration of 2\*300 mg JNJ63623872 tablets (reference formulation) and 1\*75 mg oseltamivir capsule, under fasted conditions in healthy adult participants.

Conditions

  • Healthy

Interventions

DRUG

JNJ-63623872

Participants will receive JNJ-63623872 600 mg (2\*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.

DRUG

Oseltamivir

Participants will receive Oseltamivir 75 mg (1\*75 mg) oral capsule (reference) in Treatment D of Panel 2 and Oseltamivir 75 mg administered as JNJ-63623872/37.5 mg Oseltamivir oral FDC tablet concept formulation (test 3) in Treatment E of Panel 2.

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2017-04-14
Completion
2017-04-14

Countries

  • Belgium

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 NCT03023852 on ClinicalTrials.gov