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

NCT01241409 | Completed Phase 1

• 2 other identifiers: CR014830RABGRD1007
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy; Sprinkle Capsule Formulation; Rabeprazole sodium; Pharmacokinetics; Bioequivalence; Safety

Outcome Measures

Primary Outcomes (2)

• Plasma concentrations of rabeprazole sodium

  Up to 16 hours after each study drug administration

• Plasma concentrations of thioether metabolite

  Up to 16 hours after each study drug administration

Secondary Outcomes (1)

• The number of participants with adverse events as a measure of safety and tolerability

  Up to approximately 39 days

Study Arms (6)

Treatment sequence ABC

EXPERIMENTAL

Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C

Treatment sequence ACB

EXPERIMENTAL

Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C

Treatment sequence BAC

EXPERIMENTAL

Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C

Treatment sequence BCA

EXPERIMENTAL

Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C

Treatment sequence CAB

EXPERIMENTAL

Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C

Treatment sequence CBA

EXPERIMENTAL

Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C

Interventions

Rabeprazole sodium: Treatment A DRUG

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).

Treatment sequence ABC; Treatment sequence ACB; Treatment sequence BAC; Treatment sequence BCA; Treatment sequence CAB; Treatment sequence CBA

Rabeprazole sodium: Treatment B DRUG

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).

Treatment sequence ABC; Treatment sequence ACB; Treatment sequence BAC; Treatment sequence BCA; Treatment sequence CAB; Treatment sequence CBA

Rabeprazole sodium: Treatment C DRUG

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).

Treatment sequence ABC; Treatment sequence ACB; Treatment sequence BAC; Treatment sequence BCA; Treatment sequence CAB; Treatment sequence CBA

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

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

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: October 21, 2010
• First Posted: November 16, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 30, 2012

Record last verified: 2012-10