Bioavailability/Bioequivalence
Conditions
Interventions
Product Name: Rabeprazole Sodium
Product Code: E3810
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: RABEPRAZOLE SODIUM
CAS Number: 117976-90-6
Current Sponsor code: E3810
Concentration u
Sponsors
Eisai Medical Research Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males and non-pregnant females, 19 to 45 years old with a body mass index (BMI) of 18 to 30 kg/m2 inclusive (BMI =weight (kg)/[height (m)]2). 2. Females had to be of child-bearing potential and practicing a medically acceptable method of mechanical contraception during screening and throughout the study. Postmenopausal women had to be amenorrheic for at least 12 months or have a follicle stimulating hormone (FSH) level of =40 IU/L. 3. Subjects had to be willing and able to participate in the whole study and to provide written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Evidence of significant hepatic, gastrointestinal (GI), renal, respiratory, endocrine, hematologic, neurologic, infectious, psychiatric, or cardiovascular system abnormalities. 2. Known or suspected history of alcohol or drug misuse and/or positive urine drug screen for a prohibited agent. 3. A positive test result for hepatitis B surface antigen (HBsAg), hepatitis C, or human immunodeficiency virus (HIV) screen. 4. History of allergy or hypersensitive reactions to rabeprazole sodium, substituted benzimidazoles, or any component of the vehicle. 5. History of a known genetic disorder in the enzyme that metabolizes phenylalanine (phenylketonurics ). 6. Pregnant or breast-feeding women. Note: the list is not exhaustive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was to evaluate the bioavailability of a new rabeprazole formulation, consisting of enteric-coated microgranules, relative to the currently marketed 10-mg tablet formulation.;Secondary Objective: The secondary objective was to determine the palatability of the oral suspension of rabeprazole.;Primary end point(s): Maximum drug plasma concentration (Cmax), Time of maximum observed plasma concentration (tmax), Elimination half-life during the apparent terminal disposition phase (t1/2?z), Area under the concentration-curve (AUC) from time 0 to t (AUC (0-t)), Area under the concentration-curve from time 0 to infinity (AUC (0- 8)), and log transformed values for AUC and Cmax. ;Timepoint(s) of evaluation of this end point: Predose (-1 hour) and at 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 14, and 16 hours postdose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean Palatability scores within 5 minutes of receiving the oral suspension of rabeprazole ;Timepoint(s) of evaluation of this end point: Within 5 mins of receiving the oral suspension of rabeprazole | — |
Countries
United States
Contacts
Public ContactEisai Medical Information
Eisai Medical Research Inc.
Outcome results
None listed