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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

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) \[189 kcal from fat, 268 kcal from carbohydrates, and 76 kcal from proteins\]).

Trial Locations (1)

Unknown

Antwerp

All Listed Sponsors
lead

Janssen Sciences Ireland UC

INDUSTRY

NCT02561936 - Relative Bioavailability of Three Oral Formulations Candidates of Rilpivirine for Potential Pediatric Use Compared to Oral Tablet | Biotech Hunter | Biotech Hunter