Status:
COMPLETED
A Relative Bioavailability Study of Rabeprazole Sodium Administered With Different Dosing Vehicles in Healthy Adult Volunteers
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 dif...
Detailed Description
This is an open-label (volunteer and investigator will know the name of the assigned treatment) single center study to evaluate the bioavailability (rate and extent of absorption) and safety of differ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01186497
Start Date
August 1 2010
End Date
November 1 2010
Last Update
January 23 2013
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