Evaluation of Clinical and Safety Outcomes Associated With Conversion From Brand-Name to Generic Tacrolimus Products in High Risk Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
研究概览
简要总结
The prospective study will compare the relative bioavailability at steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.
详细描述
Comparison of the relative bioavailability and steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients. Six tacrolimus formulations will be tested and each patient will receive each formulation once. As we proposed to test bioequivalence in the steady-state, patients will receive the test formulations for one week prior to pharmacokinetic evaluation. The pharmacokinetic evaluation will incorporate limited sampling strategies with a focus on fully characterizing the Cmax out to hour 4 post dose. Subsequent PK sampling and trough blood concentrations will be monitored on a daily basis using dried blood spots that the study subjects will collect by themselves at home. It will be critical that the patients are adherent to their test medication to ensure that they have reached steady state. This will be monitored using test diaries, pill counts and MEMS caps (Medication Event Monitoring System (MEMS), AARDEX Corp, Palo Alto, CA. Bioequivalence will be tested using average bioequivalence metrics. A combination of limited sampling strategy and dry spot analysis in combination with population pharmacokinetic modeling will be utilized to fully characterize the PK profile of these formulations.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sequence 1
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 1: Formulation Sandoz, Panacea, Accord, Mylan, Dr. Reddy's, Astellas
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Prograf (Drug)
Sequence 1
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 1: Formulation Sandoz, Panacea, Accord, Mylan, Dr. Reddy's, Astellas
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Sandoz (Drug)
Sequence 1
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 1: Formulation Sandoz, Panacea, Accord, Mylan, Dr. Reddy's, Astellas
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Reddy Laboratory (Drug)
Sequence 1
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 1: Formulation Sandoz, Panacea, Accord, Mylan, Dr. Reddy's, Astellas
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Mylan (Drug)
Sequence 1
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 1: Formulation Sandoz, Panacea, Accord, Mylan, Dr. Reddy's, Astellas
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Accord (Drug)
Sequence 1
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 1: Formulation Sandoz, Panacea, Accord, Mylan, Dr. Reddy's, Astellas
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Pancea Biotech Limited (Drug)
Sequence 2
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 2: Formulation Accord, Sandoz, Dr. Reddy's, Panacea, Astellas, Mylan
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Prograf (Drug)
Sequence 2
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 2: Formulation Accord, Sandoz, Dr. Reddy's, Panacea, Astellas, Mylan
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Sandoz (Drug)
Sequence 2
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 2: Formulation Accord, Sandoz, Dr. Reddy's, Panacea, Astellas, Mylan
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Reddy Laboratory (Drug)
Sequence 2
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 2: Formulation Accord, Sandoz, Dr. Reddy's, Panacea, Astellas, Mylan
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Mylan (Drug)
Sequence 2
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 2: Formulation Accord, Sandoz, Dr. Reddy's, Panacea, Astellas, Mylan
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Accord (Drug)
Sequence 2
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 2: Formulation Accord, Sandoz, Dr. Reddy's, Panacea, Astellas, Mylan
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Pancea Biotech Limited (Drug)
Sequence 3
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 3: Formulation Dr. Reddys, Accord, Astellas, Sandoz, Mylan, Panacea
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Prograf (Drug)
Sequence 3
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 3: Formulation Dr. Reddys, Accord, Astellas, Sandoz, Mylan, Panacea
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Sandoz (Drug)
Sequence 3
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 3: Formulation Dr. Reddys, Accord, Astellas, Sandoz, Mylan, Panacea
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Reddy Laboratory (Drug)
Sequence 3
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 3: Formulation Dr. Reddys, Accord, Astellas, Sandoz, Mylan, Panacea
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Mylan (Drug)
Sequence 3
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 3: Formulation Dr. Reddys, Accord, Astellas, Sandoz, Mylan, Panacea
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Accord (Drug)
Sequence 3
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 3: Formulation Dr. Reddys, Accord, Astellas, Sandoz, Mylan, Panacea
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Pancea Biotech Limited (Drug)
Sequence 4
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 4: Formulation Astellas, Dr. Reddy's, Mylan, Accord, Panacea, Sandoz
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Prograf (Drug)
Sequence 4
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 4: Formulation Astellas, Dr. Reddy's, Mylan, Accord, Panacea, Sandoz
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Sandoz (Drug)
Sequence 4
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 4: Formulation Astellas, Dr. Reddy's, Mylan, Accord, Panacea, Sandoz
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Reddy Laboratory (Drug)
Sequence 4
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 4: Formulation Astellas, Dr. Reddy's, Mylan, Accord, Panacea, Sandoz
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Mylan (Drug)
Sequence 4
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 4: Formulation Astellas, Dr. Reddy's, Mylan, Accord, Panacea, Sandoz
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Accord (Drug)
Sequence 4
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 4: Formulation Astellas, Dr. Reddy's, Mylan, Accord, Panacea, Sandoz
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Pancea Biotech Limited (Drug)
Sequence 5
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 5: Formulation Mylan, Astellas, Panacea, Dr. Reddy's, Sandoz, Accord
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Prograf (Drug)
Sequence 5
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 5: Formulation Mylan, Astellas, Panacea, Dr. Reddy's, Sandoz, Accord
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Sandoz (Drug)
Sequence 5
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 5: Formulation Mylan, Astellas, Panacea, Dr. Reddy's, Sandoz, Accord
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Reddy Laboratory (Drug)
Sequence 5
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 5: Formulation Mylan, Astellas, Panacea, Dr. Reddy's, Sandoz, Accord
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Mylan (Drug)
Sequence 5
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 5: Formulation Mylan, Astellas, Panacea, Dr. Reddy's, Sandoz, Accord
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Accord (Drug)
Sequence 5
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 5: Formulation Mylan, Astellas, Panacea, Dr. Reddy's, Sandoz, Accord
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Pancea Biotech Limited (Drug)
Sequence 6
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 6: Formulation Panacea, Mylan, Sandoz, Astellas, Accord, Dr. Reddy's
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Prograf (Drug)
Sequence 6
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 6: Formulation Panacea, Mylan, Sandoz, Astellas, Accord, Dr. Reddy's
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Sandoz (Drug)
Sequence 6
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 6: Formulation Panacea, Mylan, Sandoz, Astellas, Accord, Dr. Reddy's
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Reddy Laboratory (Drug)
Sequence 6
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 6: Formulation Panacea, Mylan, Sandoz, Astellas, Accord, Dr. Reddy's
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Mylan (Drug)
Sequence 6
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 6: Formulation Panacea, Mylan, Sandoz, Astellas, Accord, Dr. Reddy's
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Accord (Drug)
Sequence 6
Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 6: Formulation Panacea, Mylan, Sandoz, Astellas, Accord, Dr. Reddy's
Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
干预措施: Tacrolimus, Pancea Biotech Limited (Drug)
结局指标
主要结局
Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
时间窗: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.
Report the geometric mean and 95% confidence interval for AUC 0-12hr (ng\*hr/ml) for each formulation in expressor and non expressor transplant recipients
Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
时间窗: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.
Report the geometric mean and 95% confidence interval for Cmax (ng/ml) for each formulation in expressor and non expressor transplant recipients
次要结局
- To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects(Assessed at baseline and weekly for 6 weeks at each pharmacokinetic profile)
研究者
Rita Alloway
Research Professor
University of Cincinnati