A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers

NCT01101646 | Completed Phase 1

• 2 other identifiers: CR014827RABGRD1006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2 different formulations, assess the effect of food on the pharmacokinetics and assess safety of rabeprazole sodium in healthy volunteers. Rabeprazole sodium is a drug used to treat patients with Gastro Esophageal Reflux Disease (GERD). GERD is a condition in which the esophagus (tube from throat to stomach) becomes irritated or inflamed because of acid backing up from the stomach.

Conditions

Gastroesophageal Reflux

Keywords

Rabeprazole sodium; Pharmacokinetics; Biological Availability; Safety; Adult

Outcome Measures

Primary Outcomes (1)

• To evaluate the relative bioavailability of rabeprazole sodium (Phase 3 versus Phase 1 formulation) and the effect of food (Phase 3 formulation) by estimation of standard plasma PK parameters (Cmax. AUC, tmax) of rabeprazole and its major metabolite.

  Before and up to 16 hours after study drug administration on Day 1 during treatment periods 1, 2, and 3

Secondary Outcomes (1)

• To evaluate the safety and tolerability of 2 formulations of rabeprazole sodium by assessment of vital signs, clinical laboratory tests, physical examinations, ECG findings, and adverse events.

  Approximately 36 days (includes time of screening through to the end of the study or early withdrawal)

Study Arms (3)

001

EXPERIMENTAL

rabeprazole sodium four 2.5 mg capsules of the phase 3 pediatric bead formulation suspended in a strawberry flavored vehicle (taken in fasted or fed state)

Drug: rabeprazole sodium

002

EXPERIMENTAL

rabeprazole sodium two 5-mg sachets of the phase 1 pediatric bead formulation suspended in a strawberry flavored vehicle (taken in fasted state)

Drug: rabeprazole sodium

003

EXPERIMENTAL

rabeprazole sodium four 2.5 mg capsules of the phase 3 formulation sprinkled on 1 ounce of plain yogurt

Drug: rabeprazole sodium

Interventions

rabeprazole sodium DRUG

four 2.5 mg capsules of the phase 3 pediatric bead formulation suspended in a strawberry flavored vehicle (taken in fasted or fed state)

001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteer with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry, hematology, urinalysis, vital signs, and electrocardiogram (ECG)
• Agrees to abstain from alcohol intake 48 hours before each study drug administration and during the inpatient portions of the study
• Agrees not to consume food containing poppy seeds during the study or food/beverages containing grapefruit juice, seville oranges, or quinine (eg, tonic water) from 72 hours prior to Study Day -1 until after the last PK sample is collected
• Agrees to limit intake of caffeine/methylxanthine (eg, coffee, tea, chocolate, or caffeine-containing soft drinks) to less than 300 mg/day (eg, approximately 3 cups of coffee or 6 cola drinks) for the duration of the study
• Female volunteers of childbearing potential agree to use appropriate birth control method during the study

You may not qualify if:

• Currently have, or have a history of disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system that is clinically significant in the opinion of the Investigator
• Have evidence of any chronic medical conditions requiring prescription medications
• History of hypersensitivity or allergies to any drug compound, including rabeprazole sodium, substituted benzimidazoles, or any excipient used in pediatric bead formulation, unless approved by the Investigator
• Have had major or traumatic surgery within 12 weeks prior to screening or pre-planned surgery or procedures that would interfere with the conduct of the study
• Have an acute illness within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration
• Have a recent history (within previous 1 year) of alcohol or drug abuse

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

Related Publications (1)

• Thyssen A, Solanki B, Gonzalez M, Leitz G, Treem W, Mannaert E. Pharmacokinetics of rabeprazole granules versus tablets, and the effect of food on the pharmacokinetics of rabeprazole granules in healthy adults-cross-study comparison. Clin Pharmacol Drug Dev. 2014 Sep;3(5):406-16. doi: 10.1002/cpdd.118. Epub 2014 May 23.

  PMID: 27129014 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: April 12, 2010
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

US (1)