A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2 sprinkle capsule formulations of rabeprazole sodium when administered without food to healthy volunteers. In addition, the pharmacokinetics of 1 formulation of rabeprazole sodium will be evaluated when administered with food to healthy volunteers.

• 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:

• Have a body mass index (BMI) between 18 and 30 kg/m² (inclusive), and body weight not less than 50 kg

• Women 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

• Women must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period

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

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

• Exclusion Criteria:

• Currently have, or have a history of medical illness considered by the Investigator to be clinically significant or any other illness that the investigator considers should exclude the volunteer or that could interfere with the interpretation of the study results

• Have clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as deemed appropriate by the investigator

• Have clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator

• Have a history of drug or alcohol abuse within the past 1 year

• 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

• Known allergy to heparin or history of heparin-induced thrombocytopenia

• Use of any concomitant therapy which are drug metabolizing enzyme (cytochrome P450) inducers or inhibitors within 6 weeks before study entry and during the entire study

• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, hormonal contraceptives and hormonal replacement therapy, within 14 days before the first dose of the study drug is scheduled