Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Rabeprazole Sodium Delayed Release Tablets Under Fasted Conditions

NCT01990378 | Completed Phase 1

• 1 other identifier: PK-10-066
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Rabeprazole Sodium Delayed Release Tablets 20 mg and Aciphex® Delayed Release Tablets 20 mg (Reference, Eisai Inc., USA). Dosing periods were separated by a washout period during fasted study. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• bioequivalence based on Composite of Pharmacokinetics

  bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.

  plasma samples were obtained from blood drawn at Pre-dose and 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 14.00, 18.00 and 24.00 hours after dose administration

Interventions

Rabeprazole sodium 20 mg Delayed Release tablet DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male human volunteers within the age range of 18 to 50 years
• A body mass index within 18-25 Kg/m2
• Given written informed consent to participate in the study
• Absence Of disease markers of HIV 1\& 2, hepatitis B \& C virus and RPR.
• Absence of significant disease or clinically' significant abnormal laboratory values on laboratory evaluation, medical history and medical examination during the screening
• A normal 12 lead ECG.
• A normal chest X-ray (FA view)
• Comprehension of the nature and purpose'of the study and compliance with the requirement of the entire protocol
• No history or no evidence of hypersensitivity to rabeprazole substituted benzimidazoles or to any component of the formulation
• No history of Anaphylaxis arid Angioedema
• No history or presence of gastric malignancy
• No history of significant systemic diseases
• No history of psychiatric disorders
• No history of addiction to any recreational drug or drug dependence
• No donation of blood(one unit or 350 mL) within 90 days prior to study check-in

You may not qualify if:

• History of seizures
• Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study
• History of alcohol consumption for more than two units/day (1 unit=30 mL of spirit/or 1 pint of beer), or having consumed alcohol within 48.0 hours prior to check-in
• High caffeine (more than 5 cups of coffee or tea/day) or tobacco (mote than 9 cigarettes/beedies/cigars per day) consumption
• History of difficulty with donating blood or difficulty in accessibility of veins
• An unusual or abnormal diet for whatever reason e.g. because of fasting due to religious reasons

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

Study Sites (1)

AXIS Clinicals Limited

Miyāpur, Hyderabad, 500 050, India

Location

MeSH Terms

Interventions

Rabeprazole; Tablets, Enteric-Coated

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; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations; Tablets

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Primary Completion: September 1, 2010
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

IN (1)