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

Launched by TORRENT PHARMACEUTICALS LIMITED · Nov 15, 2013

Keywords

ClinConnect Summary

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Gender

MALE

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