Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects

Exclusion Criteria

• •Subjects meeting any of the following criteria will be excluded:
• •Known history of hypersensitivity to pravastatin sodium (e.g. Pravachol®, Lipostat®) and/or related drugs such as simvastatin (Zocor®), atorvastatin (Lipitor™), cerivastatin (Baycol®) or fluvastatin (Lescol®).
• •Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator, or medical designate.
• •Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• •Any clinically significant illness during the last four weeks prior to entry into this study.
• •Presence of any significant physical or organ abnormality.
• •Any subject with a history of drug abuse.
• •Any psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.
• •Use of any prescription medication within 14 days preceding entry into this study.
• •Use of over-the-counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).
• •Female subjects: use of oral contraceptives or contraceptive implants (such as Norplant®) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.
• •Female subjects: presence of pregnancy or lactation.
• •Any subject who has had blood withdrawals within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
• •Participation in a clinical trial with an investigational drug within 30 days preceding this study.
• •Any subject who has donated blood within 56 days preceding this study.
• •Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.
• •Significant or recent history of asthma (after 12 years of age).
• •Any subject with a recent (less than one year) history of alcohol abuse.