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

An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of Rabeprazole Sodium Delayed Release Tablets 20 mg (Test, Torrent Pharmaceuticals Limited., India) Versus Aciphex® (Rabeprazole Sodium) Delayed Release Tablets 20 mg (Reference, Eisai Inc., USA) in Healthy Human Volunteers Under Fasting Condition.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Rabeprazole sodium 20 mg Delayed Release tablet

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Hyderabad
    • Miyapur, Hyderabad, India, 500 050
      • Axis Clinicals Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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
• No participation in any clinical study within the last 90 days
• No receipt of any prescription drugs or over-the-counter drugs (e.g.: Cold preparations, and antacid preparations' vitamins and natural products used for therapeutic benefits), within two weeks prior to study check-in
• No history of dehydration from diarrhea, vomiting or any other reason within a period of 24.0 hours prior to study check-in
• No family history of neurological disorders
• Not consumed alcohol and xanthin containing food and beverages, (chocolates, tea,coffee or cola drinks) cigarettes and tobacco products for at least 48.0 hours prior to study check-in for each period.
• Negative results for drugs of abuse (Benzodiazepines, Cocaines, Opioids, Amphetamines, Cannabinoids and Barbiturates) in urine during the day of study check-in of each period
• Not consumed grapefruit(mosumbi/sweet lime) juice within the 48.0 hours prior to study check-in
• Negative alcohol breath analysis during the study check-in of each period

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Torrent Pharmaceuticals Limited

Study record dates

Study Major Dates

• Primary Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Estimate): November 21, 2013
• Last Update Submitted That Met QC Criteria: November 15, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: PK-10-066