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

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