Pharmacokinetics of Mycophenolate Mofetil in Healthy Volunteers

Exclusion Criteria

• •Children and adolescents less than 18 years of age
• •Individuals who smoke or have excessive alcohol (greater than 1 beer or an equivalent alcoholic beverage per day)
• •Pregnant women and nursing mothers
• •Subjects with certain underlying diseases which include diabetes, cardiovascular diseases, liver diseases, cancer, and human immunodeficiency virus infection
• •Individuals with compromised immune systems
• •Subjects who have an active infection
• •Individuals with history of biliary tract disease, and biliary or gastrointestinal surgery
• •Subjects with persistent diarrhea or other gastrointestinal problems that could impede drug absorption
• •Subjects with abnormal liver and kidney functions as determined by medication history and laboratory evaluation (AST and ALT less than or equal to 2 x upper normal limit, total bilirubin less than or equal to 1 mg/dL, serum creatinine less than or equal to 1.2 mg/dL, hemoglobin greater than or equal to 11 g/dL, WBC greater than or equal to 3.5 x 10(9)/L)
• •Volunteers on chronic prescribed and over-the-counter medications, and dietary and herbal supplements within 4 weeks of study participation
• •Subjects who are taking any medications that could potentially interact with MMF pharmacokinetically and pharmacodynamically such as eccinacea, iron preparations, antacids, bile-resin cholesterol lowering agents, and steroids.
• •Volunteers with documented allergy to MMF
• •Prior enrollment into a similar study within the past two months and enrollment in another study at the same time
• •Subjects who are felt to be unwilling or unable to practice effective contraception methods or comply with protocol specifications