A multicenter, randomized, open label, two treatment, twoperiod, two sequence, single-dose, two-way, crossover, bioequivalence study of Methotrexate Tablets USP, 2.5 mg manufactured by Amneal Pharmaceuticals, withMethotrexate Tablets USP 2.5 mg Manufactured for DAVAPharmaceuticals, Inc., Fort Lee, NJ 07024 USA in patientswith mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of 2.5 mg every 12 hours under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- To characterize the pharmacokinetic profile of Methotrexate Tablets USP, 2.5 mg of Amneal Pharmaceuticals, compared to that of the Methotrexate Tablets USP 2.5 mg manufactured for DAVA Pharmaceuticals, Inc., Fort Lee, NJ 07024 USA in patients with mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of 2.5 mg every 12 hours for three doses per week under fasting conditions, and to assess their bioequivalence.
研究概览
简要总结
To compare and evaluate the bioequivalence study of Methotrexate Tablets 2.5 mg (manufactured by Amneal Pharmaceuticals) with Methotrexate Tablets USP 2.5 mg (DAVA Pharmaceuticals, Inc.,Fort Lee, NJ 07024 USA) in patients with mild to severe psoriasis or rheumatoid arthritis (RA), who are already on established regimens of 2.5 mg every 12 hours under fasting condition. Total expected duration of the study will be of at least 8 days from the day of admission of the first period till the end of study sample collection in period II. There will be at least 7 days duration between the IMP administrations in two study periods. After IMP administration in each period (on day 1), patients will be advised to receive their scheduled dose of 2.5 mg Methotrexate tablet 12 hours apart for additional 2 doses using locally approved drug. A total of 22 PK samples will be collected during each period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Men or Women, between 18 to 65 years of age (both inclusive).
- •2.Ability to provide informed consent prior to participation in the study 3.Patients with mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of 2.5 mg every 12 hours (7.5 mg per week in three divided doses).
- •4.Confirmed diagnosis of psoriasis by clinical examination or after dermatologic consultation.
- •or Confirmed diagnosis of mild to severe rheumatoid arthritis based on at least 1 of the following: i.Documented history of positive rheumatoid factor ii.Current presence of rheumatoid factor iii.Radiographic erosion within 12 months prior to enrollment iv.Presence of serum anti-cyclic citrullinated peptide antibodies (anti-CCP).
- •5.Women of childbearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation within past 6 months) must have a negative serum pregnancy test at screening and negative urine pregnancy test on check in to housing, and must agree to use an adequate method of contraception.
- •6.Patient’s screening laboratory assessment (complete blood count [CBC] and blood chemistries) are clinically non-significant as per the discretion of the Investigator.
- •7.No history of addiction to any recreational drug or drug dependence.
- •8.No participation in any clinical study within the past 60 days prior to receiving the first dose of investigational product for the current study.
排除标准
- •1.A history of allergic or adverse reactions to Methotrexate Sodium or any related drug or any excipient of methotrexate tablets.
- •2.Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial and at least for 3 months (for males) and for at least one ovulatory cycle (for females) after last dose of study medication.
- •3.Patients with alcoholism, alcoholic liver disease or other chronic liver disease.
- •4.Patients who are diagnosed to be HIV or Hepatitis B or Hepatitis C Virus reactive/positive.
- •5.Patients who have clinically significant abnormal laboratory values at screening.
- •6.Patients with any evidence of organ dysfunction or any clinically significant deviation from normal in their physical or clinical evaluation including ECG and X-ray results except study indication.
- •7.Patients who have overt or laboratory evidence of immunodeficiency syndromes.
- •8.Patients currently suffering from or having a history of malignant lymphoma or tumor lysis syndrome.
- •9.Patients who have pre-existing hematopoietic impairment/ blood dyscrasias, such as bone marrow hypoplasia, aplastic anemia, pancytopenia, leukopenia, neutropenia, thrombocytopenia and or significant anemia.
- •10.Patient with lymphadenopathy and lymphoproliferative disorders.
结局指标
主要结局
To characterize the pharmacokinetic profile of Methotrexate Tablets USP, 2.5 mg of Amneal Pharmaceuticals, compared to that of the Methotrexate Tablets USP 2.5 mg manufactured for DAVA Pharmaceuticals, Inc., Fort Lee, NJ 07024 USA in patients with mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of 2.5 mg every 12 hours for three doses per week under fasting conditions, and to assess their bioequivalence.
时间窗: The pre-dose blood sample (00.00) will be collected within 5 minutes before dosing on Day 1 of each period. On day 1, the post-dose blood samples will be drawn at 0.167, 0.333, | 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 7.000, 8.000, 10.000 and 12.000 following drug administration in each | period.
次要结局
- To monitor the adverse events and to ensure the safety of Patient(NA)