bioequivalence study of torrent pharmaceutical ltd.'s rabeprazole sodium delayed release tablets under fed conditions

Conditions: Healthy

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 fed study. study design: open-label, randomised, two period, two treatment, crossover, single-dose bioequivalence study


Eligibility 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