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

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Rabeprazole sodium: Treatment A Drug: Rabeprazole sodium: Treatment B Drug: Rabeprazole sodium: Treatment C	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Rabeprazole Rabeprazole sodium

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	78
Study Start Date:	October 2010
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment sequence ABC	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 ACB	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 BAC	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 BCA	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 CAB	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 CBA	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).

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241409

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

No publications provided

Responsible Party:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT01241409 History of Changes
Other Study ID Numbers:	CR014830, RABGRD1007
Study First Received:	October 21, 2010
Last Updated:	October 28, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Healthy
Sprinkle Capsule Formulation
Rabeprazole sodium
Pharmacokinetics

Bioequivalence
Safety
bioequivalence

Additional relevant MeSH terms:

Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013