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A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers

NCT01101646 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-05-28

No results posted yet for this study

Summary

The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2 different formulations, assess the effect of food on the pharmacokinetics and assess safety of rabeprazole sodium in healthy 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

  • Gastroesophageal Reflux

Interventions

DRUG

rabeprazole sodium

four 2.5 mg capsules of the phase 3 pediatric bead formulation suspended in a strawberry flavored vehicle (taken in fasted or fed state)

DRUG

rabeprazole sodium

two 5-mg sachets of the phase 1 pediatric bead formulation suspended in a strawberry flavored vehicle (taken in fasted state)

DRUG

rabeprazole sodium

four 2.5 mg capsules of the phase 3 formulation sprinkled on 1 ounce of plain yogurt

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
2008-08-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

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 NCT01101646 on ClinicalTrials.gov