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

Completed · Phase 1

Conditions studied: Gastroesophageal Reflux

In brief

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.

Key facts

Study ID: NCT01101646
Run by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
People needed: 36
Starts: 2008-08-01
Expected to finish: 2008-09-01
Last updated by the study team: 2014-05-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy volunteer with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry, hematology, urinalysis, vital signs, and electrocardiogram (ECG)
Agrees to abstain from alcohol intake 48 hours before each study drug administration and during the inpatient portions of the study
Agrees not to consume food containing poppy seeds during the study or food/beverages containing grapefruit juice, seville oranges, or quinine (eg, tonic water) from 72 hours prior to Study Day -1 until after the last PK sample is collected
Agrees to limit intake of caffeine/methylxanthine (eg, coffee, tea, chocolate, or caffeine-containing soft drinks) to less than 300 mg/day (eg, approximately 3 cups of coffee or 6 cola drinks) for the duration of the study
Female volunteers of childbearing potential agree to use appropriate birth control method during the study

You may not qualify if…

Currently have, or have a history of disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system that is clinically significant in the opinion of the Investigator
Have evidence of any chronic medical conditions requiring prescription medications
History of hypersensitivity or allergies to any drug compound, including rabeprazole sodium, substituted benzimidazoles, or any excipient used in pediatric bead formulation, unless approved by the Investigator
Have had major or traumatic surgery within 12 weeks prior to screening or pre-planned surgery or procedures that would interfere with the conduct of the study
Have an acute illness within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration
Have a recent history (within previous 1 year) of alcohol or drug abuse

Where it is running

Study site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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