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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01241409
First received: October 21, 2010
Last updated: October 28, 2012
Last verified: October 2012

October 21, 2010
October 28, 2012
October 2010
December 2010   (final data collection date for primary outcome measure)
  • Plasma concentrations of rabeprazole sodium [ Time Frame: Up to 16 hours after each study drug administration ] [ Designated as safety issue: No ]
  • Plasma concentrations of thioether metabolite [ Time Frame: Up to 16 hours after each study drug administration ] [ Designated as safety issue: No ]
Plasma concentrations of rabeprazole sodium and its major metabolite and the derived standard plasma PK parameters (Cmax, AUC, tmax) [ Time Frame: At protocol-specified time points before and up to 16 hours after each study drug administration performed over a period of up to 18 days. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01241409 on ClinicalTrials.gov Archive Site
The number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to approximately 39 days ] [ Designated as safety issue: No ]
  • The number and type of adverse events reported [ Time Frame: At protocol-specified time points from the screening phase through study completion (up to approximately 39 days) ] [ Designated as safety issue: No ]
  • Clinically relevant changes in clinical laboratory test results [ Time Frame: At protocol-specified time points from the screening phase through study completion (up to approximately 39 days) ] [ Designated as safety issue: No ]
  • Results from electrocardiogram and vital signs measurements [ Time Frame: At protocol-specified time points from the screening phase through study completion (up to approximately 39 days) ] [ Designated as safety issue: No ]
  • Assessment of findings from physical examinations. [ Time Frame: At protocol-specified time points from the screening phase through study completion (up to approximately 39 days) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers
Pivotal Study to Assess the Bioequivalence of the To-be-Marketed Sprinkle Capsule Formulation and the Phase 3 Sprinkle Capsule Formulation of Rabeprazole Sodium in Fasted Condition and to Assess the Effect of Food on the To-be-Marketed Formulation in Healthy Adult Subjects

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.

This is a randomized (study drug assigned by chance), open-label (the volunteer will know the treatment/drug they are taking), single-dose study of 2 formulations of rabeprazole sodium in healthy adult volunteers. Rabeprazole sodium is a drug used to treat patients with Gastroesophageal Reflux Disease (GERD), a condition where the esophagus (tube from throat to stomach) becomes irritated or inflamed as a result of acid that backs up into the esophagus from the stomach. All volunteers will receive 3 doses of study drug; each dose of study drug will be separated by at least 7 days. Blood samples will be collected from volunteers during the study to measure the concentration of study drug. Approximately 78 healthy volunteers will be enrolled and will participate in the study for a total of approximately 39 days. During the study, the healthy volunteer will make a total of approximately 4 visits to the study center. The 4 visits will include an initial screening visit and 3 visits to receive study drug. Volunteers will be required to stay at the study center for at least 12 hours before study drug administration and up to approximately 24 hours after study drug administration to have study procedures performed and blood samples collected to measure the concentrations of rabeprazole and its thioether metabolite (a substance produced when rabeprazole is metabolized in the body) in the plasma (ie, the clear liquid portion of blood). Volunteers will be monitored for safety throughout the study. Healthy volunteers will receive a single dose of study drug in 3 treatment periods. In each treatment period, healthy volunteers will receive one 10 mg capsule of rabeprazole sodium or two 5 mg capsules of rabeprazole sodium. The contents of study drug capsules will be sprinkled on 1 tablespoon of applesauce and administered orally (by mouth) to healthy volunteers in the morning who have fasted (not eaten) overnight and to those who have eaten a standardized breakfast.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Rabeprazole sodium: Treatment A
    One single oral dose of 10 mg (1 x 10-mg capsule) rabeprazole to be-marketed sprinkle capsule granule formulation administered in fasted state. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).
  • Drug: Rabeprazole sodium: Treatment B
    One single oral dose of 10 mg (2 x 5-mg capsules) rabeprazole Phase 3 sprinkle capsule granule formulation administered in fasted state. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).
  • Drug: Rabeprazole sodium: Treatment C
    One single oral dose of 10 mg (1 x 10-mg capsule) rabeprazole to be-marketed sprinkle capsule granule formulation administered after consumption of a standardized high-fat high-caloric breakfast. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).
  • Experimental: Treatment sequence ABC
    Interventions:
    • Drug: Rabeprazole sodium: Treatment A
    • Drug: Rabeprazole sodium: Treatment B
    • Drug: Rabeprazole sodium: Treatment C
  • Experimental: Treatment sequence ACB
    Interventions:
    • Drug: Rabeprazole sodium: Treatment A
    • Drug: Rabeprazole sodium: Treatment B
    • Drug: Rabeprazole sodium: Treatment C
  • Experimental: Treatment sequence BAC
    Interventions:
    • Drug: Rabeprazole sodium: Treatment A
    • Drug: Rabeprazole sodium: Treatment B
    • Drug: Rabeprazole sodium: Treatment C
  • Experimental: Treatment sequence BCA
    Interventions:
    • Drug: Rabeprazole sodium: Treatment A
    • Drug: Rabeprazole sodium: Treatment B
    • Drug: Rabeprazole sodium: Treatment C
  • Experimental: Treatment sequence CAB
    Interventions:
    • Drug: Rabeprazole sodium: Treatment A
    • Drug: Rabeprazole sodium: Treatment B
    • Drug: Rabeprazole sodium: Treatment C
  • Experimental: Treatment sequence CBA
    Interventions:
    • Drug: Rabeprazole sodium: Treatment A
    • Drug: Rabeprazole sodium: Treatment B
    • Drug: Rabeprazole sodium: Treatment C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01241409
CR014830, RABGRD1007
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP