OPEN LABEL PHARMACOKINETIC BIOAVAILABILITY EVALUATION OF MYCOPHENOLATE MOFETIL

本研究的主要目的是比较阿司匹林的生物利用度 试验性静脉制剂至批准的口服制剂 免疫抑制药霉酚酸酯。口服MMF已开始 移植后72小时内联合环孢素和 类固醇被证明在预防肾移植方面是安全有效的。 被拒绝，最近被批准用于该用途。有一些特定的原因 不能给病人口服药物的情况，例如 肾移植后立即，肝脏或胰腺后 移植，或在肠梗阻或严重恶心呕吐的情况下。 因此，患有这些疾病的患者不能接受MMF治疗，并可能 增加了被拒绝的风险。其他免疫抑制药物，如 静脉注射中有硫唑嘌呤、环孢素和类固醇。 形式，并在有指示时使用。静脉注射MMF的安全性越来越高 在我们参与的另一项研究中进行了全面的分析。那里 没有看到重大的毒性反应。

The primary purpose of this study is to compare the bioavailability of an experimental intravenous formulation to the approved oral formulation of the immunosuppressive drug, mycophenolate mofetil. Oral MMF started within 72 hours after transplant in combination with cyclosporine and steroids was shown to be safe and effective at preventing renal allograft rejection and was recently approved for that use. There are certain instances in which oral medication cannot be given to a patient, such as immediately after renal transplant, after liver or pancreas transplantation, or in the case of ileus or severe nausea and vomiting. Patients with these conditions cannot therfore receive MMF and may be at increased risk of rejection. Other immunosuppressive drugs, such as azathioprine cyclosporine and steroids are available in the intravenous form and are used when indicated. The safety of IV MMF is being more completely analyzed in a separate study in which we participated. There have been no major toxicities seen.