Comparative Bioavailability of Myfenax® (Teva) and CellCept® (Roche) in Stable Patients After Renal Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 43
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Mycophenolate Mofetil
研究概览
简要总结
The purpose of the study is to further investigate how much of the drug substance "mycophenolate mofetil" can be found in the blood of patients with kidney or renal transplants when treated with Myfenax® or CellCept®. Additionally, the safety and side effects of the two products will be compared. All information already available on these products indicates that the safety profiles of the two products will be the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplant recipients at least 12 months post-transplantation aged ≥ 18 years.
- •Maintenance treatment with mycophenolate mofetil (in combination with tacrolimus with or without corticosteroids).
- •Stable dose of mycophenolate mofetil (≥ 500 mg twice daily) with no changes in immunosuppressive regimen for at least 6 weeks prior to the start of the study.
- •Stable renal graft function for at least 3 months.
- •Female patients must be either post-menopausal for ≥ 1 year, be surgically sterilized or a negative pregnancy test will be required immediately prior to study entry and such patients must continue to use effective contraception.
- •Willingness to undergo the study-related procedures.
- •Ability to comprehend and willingness to sign informed consent form.
排除标准
- •History of allergy to mycophenolate mofetil, mycophenolic acid or any of the ingredients.
- •Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any organ other than kidney.
- •Rejection within the past 6 months prior to the start of the study.
- •Severe clinically relevant co-existing disease.
- •History of cancer other than skin cancer that has been cured.
- •History of serious clinically relevant digestive system disease during the last 12 months prior to start of the study.
- •Known or suspected hereditary deficiency of hypoxanthine-guanine-phosphoribosyltransferase (e.g., Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome).
- •Known or suspected liver impairment.
- •Clinically significant thrombocytopenia, anaemia, leukopenia, or neutropenia
- •Clinically significant laboratory and/or physical changes during the last 2 months prior to the start of the study.
- •Use of azathioprine, cholestyramine, sevelamer, or probenecid within 2 weeks prior to the first administration of study medication.
- •Change in concomitant medication during the 6 weeks prior to start of the study.
- •Use of any drug, prescribed or over-the-counter, (except stable concomitant medication) within 2 weeks prior to the first administration of study medication.
- •Planned or expected requirement for the use of live attenuated vaccines during the study.
- •Positive testing for HIV, Hepatitis B and C.
- •Clinical symptoms or laboratory evidence of cytomegalovirus infection in the last 6 month.
- •Pregnant or breast-feeding women.
- •Women of childbearing potential unable or unwilling to practice effective contraceptive measures for the duration of the study and for 6 weeks after the end of the study.
- •History of known or suspected alcohol or drug abuse.
- •Any other condition of the patient that, in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient's compliance or adherence to protocol requirements.
- •Previous enrollment in this study or participation in any other drug investigational trial within the past 6 weeks prior to enrollment.
研究组 & 干预措施
Reference/Test/Test
The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
干预措施: mycophenolate mofetil (Myfenax) (Drug)
Reference/Test/Test
The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
干预措施: mycophenolate mofetil (Cellcept) (Drug)
Test/Reference/Reference
The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
干预措施: mycophenolate mofetil (Myfenax) (Drug)
Test/Reference/Reference
The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
干预措施: mycophenolate mofetil (Cellcept) (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Mycophenolate Mofetil
时间窗: Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
Cmax was directly obtained from measured values of plasma concentrations.
Area Under the Plasma Concentration-time Curve (AUC(0-tau)) of Mycophenolate Mofetil
时间窗: Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
For participants with a 0-12h profile: Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 12 hours). For participants with a 0-6h profile: AUC(0-tau) was calculated based on AUC(0-6h) using the extrapolation formula according to Fleming.
Area Under the Plasma Concentration-time Curve (AUC(0-6h)) of Mycophenolate Mofetil
时间窗: Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 6 hours).
次要结局
- Time Corresponding to Occurrence of Cmax (Tmax) of Mycophenolate Mofetil(Day 14 and Day 28 (end of first two cross-over periods) before drug administration)
- Summary of Participants With Adverse Events(Day 1 up to Day 112)
- Degree of Fluctuation of the Concentration Levels of Mycophenolate Mofetil Over One Dosing Interval (PTF)(Day 14 and Day 28 (end of first two cross-over periods) before drug administration)
- Minimum Observed Plasma Concentration (Cmin) of Mycophenolate Mofetil(Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration)
- Plasma Concentrations of Mycophenolate Mofetil in Pre-Administration Samples (Cpd)(Day 14 and Day 28 (end of first two cross-over periods) before drug administration)