Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
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
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Torrent Pharmaceuticals Limited
Treatments:
Rabeprazole
Criteria
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