Bioequivalence Study of Oseltamivir Phosphate and TAMIFLU Under Fed Condition in Healthy Volunteers

Exclusion Criteria

• •Hypersensitivity to Oseltamivir or related class of drugs or any of its excipients or to heparin.
• •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to dosing of period 01.
• •Presence of significant alcoholism or drug abuse.
• •History or presence of significant smoking (more than 10 cigarettes or beedis/day).
• •History or presence of asthma, urticaria or other significant allergic reactions.
• •History or presence of significant gastric and/or duodenal ulceration or gastrointestinal (GI) bleeding.
• •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
• •History or presence of cancer or basal or squamous cell carcinoma.
• •Difficulty with donating blood.
• •Difficulty in swallowing solids like tablets or capsules.
• •Use of any prescribed medication or OTC medication within 30 days prior to dosing in period 01.
• •Major illness within past 3 months.
• •Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
• •Consumption of xanthine-containing products, tobacco containing products or alcohol within 48 hours prior to dosing of period 01.
• •Consumption of grapefruit or grapefruit juice containing products within 72 hours prior to dosing of period 01.
• •Positive screening test result for any one or more: HIV, Hepatitis B and Hepatitis C.
• •History or presence of significant easy bruising or bleeding.
• •History or presence of significant recent trauma.
• •Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
• •Female subjects who are currently breast feeding.