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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Rabeprazole

Criteria

Inclusion Criteria:

• Healthy adult volunteers with a body mass index (ie, the relationship between a person's height and weight) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg

• Have normal blood pressure between 90 and 140 mmHg systolic and <=90 mmHg diastolic

• Female volunteers must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on the day before each treatment period

• Female volunteers must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if of childbearing potential and sexually active, be practicing an effective method of birth control before entry and throughout the study

• Male volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator

Exclusion Criteria:

• Currently have, or have a history of clinically significant medical illness that the investigator considers should exclude the volunteer or that could interfere with the interpretation of the study results

• Have a history of drug or alcohol abuse within the past 1 year or a history of clinically significant allergies, especially known hypersensitivity or intolerance to milk products

• Have a history of smoking or use of nicotine-containing substances within the previous 2 months

• Have had major or traumatic surgery within 12 weeks before screening or preplanned surgery or procedures that would interfere with the conduct of the study

• known allergy to the study drug or any of the excipients of the formulation or known allergy to heparin or history of heparin-induced thrombocytopenia