CTRI/2010/091/000328Other不适用
An Open Label, Balanced, Randomized, Multicentre, Single-Dose, Three-Period, Two-Treatment, Three-Sequence, Crossover Comparative Bioequivalence Study of Two Formulations of 6-Mercaptopurine in Adult patients with Acute Lymphoblastic Leukemia (ALL) under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- Other
- 发起方
- Orion Pharma
- 入组人数
- 39
- 试验地点
- 17
- 主要终点
- To characterize the pharmacokinetic profile of test formulation relative to that of the reference and to assess their bioequivalence.
研究概览
简要总结
This is an Open Label, Balanced, Randomized, Multicentre, Single-Dose, Three-Period, Two-Treatment, Three-Sequence, Crossover bioequivalence study of two formulations of mercaptopurine in patients of acute lymphoblastic leukemia. It is expected that sponsor test formulation will show pharmacokinetics similar to that of the reference listed drug and will prove bioequivalent to the reference drug. The trial will be conducted in Indian patients only and within India only. The date for first patient screened for the study is March 07 2011.
研究设计
- 研究类型
- Ba/be
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •The patients who qualify for the study should meet all of the following inclusion criteria.
- •Adult patients, either sex, aged between 18 ?
- •75 years (both inclusive).
- •Patients of acute lymphoblastic leukemia (ALL) on maintenance therapy with once daily oral 6-MP and once weekly methotrexate, and the additional drugs (for example Daunorubicin, Doxorubicin, L-asparaginase, Vincristine, Methotrexate and Steroids) as per institutional or hospital?s guidelines.
- •BMI between 18.5 kg/m2 ?
- •30 kg/ m2 both inclusive.
- •Patients Screening clinical laboratory results are within clinically acceptable range
- •Patients are willing and able to adhere to the study visit schedule and other protocol requirements as evidenced by signed written informed consent.
- •Women of child-bearing potential and all men must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication.
- •Acceptable methods of contraception include hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm), intrauterine device (IUD), and abstinence (no sex).
- •Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception while participating in the study;
- •Female patients of child-bearing potential must have a negative serum pregnancy test (beta-HCG) at screening and urine pregnancy test at the time of enrollment.
排除标准
- •The patients meeting with any of the following criteria should be excluded:
- •Adult patients with ALL on maintenance therapy with olsalazine, mesalazine, or sulphasalazine, warfarin, allopurinol, thioguanine, and drugs whose primary or secondary toxicity is myelosuppression (for example trimethoprim-sulfamethoxazole).
- •Patients with inherited deficiency of the TPMT enzyme.
- •Pregnancy, expected pregnancy or lactation within 6 months.
- •Patients who have a history of a known allergy/sensitivity to study drug or its excipients;
- •Patients who have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic(other than ALL), endocrine, pulmonary, cardiac, neurologic, or cerebral diseases;
- •Patients who have poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period;
- •Patients who have had a known substance abuse or dependency (drug or alcohol) within 3 years of screening;
- •Patients who are participating in any other clinical study or who have received treatment with any investigational drug or device within 1month prior screening; Note: If the patient has participated in a study in which blood loss is more than 200 mL, patient can be dosed only after completion of 60 days from the previous study.
- •Patient who is part of the staff or a family member of the staff personnel directly involved with this study.
- •Any other condition that, in the investigator?s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory information needed to achieve the objectives of the study.
- •Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
- •Patients who have a known infection with human immunodeficiency virus (HIV) and/or hepatitis B or hepatitis C.
结局指标
主要结局
To characterize the pharmacokinetic profile of test formulation relative to that of the reference and to assess their bioequivalence.
时间窗: Multiple time points up to 8 hours in each period
次要结局
- To assess the safety and tolerability of the two formulations(Through out the study period)
研究者
研究点 (17)
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