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A Relative Bioavailability Study of Rabeprazole Sodium Administered With Different Dosing Vehicles in Healthy Adult Volunteers

NCT01186497 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2013-01-23

No results posted yet for this study

Summary

The purpose of the study is to investigate the bioavailability (rate and extent of absorption) of rabeprazole sodium when a sprinkle capsule granule formulation of rabeprazole sodium is mixed with different dosing vehicles (food, others) and is administered to healthy adult volunteers. Rabeprazole sodium is a drug used to treat patients with Gastro Esophageal Reflux Disease (GERD). GERD is a condition in which the esophagus (tube from throat to stomach) becomes irritated or inflamed because of acid backing up from the stomach.

Conditions

  • Healthy

Interventions

DRUG

Rabeprazole sodium: Treatment E

The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a tablet vehicle suspension (Treatment E) on Day 1.

DRUG

Rabeprazole sodium: Treatment C

The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of applesauce (Treatment C) on Day 1.

DRUG

Rabeprazole sodium: Treatment D

The contents of 2 rabeprazole sprinkle capsules containing 10 mg rabeprazole sodium mixed with 5 mL (1 teaspoon) of formula milk (Treatment D) on Day 1.

DRUG

Rabeprazole sodium: Treatment A

The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a strawberry-flavored vehicle suspension (Treatment A) on Day 1.

DRUG

Rabeprazole sodium: Treatment B

The contents of 2 rabeprazole sodium sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of plain yogurt (Treatment B) on Day 1.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-11-30
Completion
2010-11-30

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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 NCT01186497 on ClinicalTrials.gov