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

NCT02561936 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-02-03

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

DRUG

Rilpivirine Oral Tablet

Rilpivirine formulated as 25 mg oral tablet.

DRUG

Rilpivirine formulation G007

Rilpivirine G007 formulation as 10\*2.5 mg tablets.

DRUG

Rilpivirine formulation G009-01

Rilpivirine G009-01 formulation as 10\*2.5 mg tablets.

DRUG

Rilpivirine formulation G002

Rilpivirine G002 formulation as 10 g of 2.5 milligram per gram (mg/gm) granules.

DIETARY_SUPPLEMENT

Standardized Breakfast

It will consist of (or its equivalent) 4 slices of bread, 2 slices of ham and/or cheese, butter, fruit preserve and 1 or 2 cups (up to 480 milliliter \[mL\]) of decaffeinated coffee or decaffeinated tea with milk and/or sugar, if desired (containing approximately fat: 21 gram (gm), carbohydrates: 67 gm, proteins: 19 gm; calories 533 kilocalorie (kcal) \[189 kcal from fat, 268 kcal from carbohydrates, and 76 kcal from proteins\]).

Sponsors & Collaborators

  • Janssen Sciences Ireland UC

    lead INDUSTRY

Principal Investigators

  • Janssen Sciences Ireland UC Clinical Trial · Janssen Sciences Ireland UC

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
2015-10-31
Primary Completion
2016-04-30
Completion
2016-04-30

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 NCT02561936 on ClinicalTrials.gov