CTRI/2010/091/000328Other未知
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. - Nill
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
- Orion Pharma
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •The patients who qualify for the study should meet all of the following inclusion criteria.
- •1. Adult patients, either sex, aged between 18 ? 75 years (both inclusive).
- •2. 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.
- •3. BMI between 18.5 kg/m2 ? 30 kg/ m2 both inclusive.
- •4. Patients Screening clinical laboratory results are within clinically acceptable range
- •5. Patients are willing and able to adhere to the study visit schedule and other protocol requirements as evidenced by signed written informed consent.
- •6. 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;
- •7. 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:
- •1. 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).
- •2. Patients with inherited deficiency of the TPMT enzyme.
- •3. Pregnancy, expected pregnancy or lactation within 6 months.
- •4. Patients who have a history of a known allergy/sensitivity to study drug or its excipients;
- •5. 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;
- •6. Patients who have poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period;
- •7. Patients who have had a known substance abuse or dependency (drug or alcohol) within 3 years of screening;
- •8. 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.
- •9. Patient who is part of the staff or a family member of the staff personnel directly involved with this study.
- •10. 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.
- •11. Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
- •12. Patients who have a known infection with human immunodeficiency virus (HIV) and/or hepatitis B or hepatitis C.
研究者
相似试验
尚未招募
Unknown
Effect of paclitaxel protein-bound particles for injectable suspension in breast cancer patients.CTRI/2024/04/065727Dr Reddys Laboratories Limited
进行中（未招募）
不适用
A study of Capecitabine 200 mg/ ml with Xeloda 500 mg (Capecitabine) at a dose of 2000 mg in adult human cancer patients under fed conditions.CTRI/2020/10/028417Shilpa Medicare Limited
进行中（未招募）
Unknown
euprolide acetate in the treatment of Prostate Cancer.CTRI/2023/09/057619Pharmathen S.A.
已完成
不适用
Imatinib Mesylate Oral Solution 400mg/5ml with Gleevec® (Imatinib mesylate) Tablets 400mg in adult human subjects with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.CTRI/2020/03/024404Shilpa Medicare Limited35
已完成
不适用
Open label multicenter randomized parallel single-period single dose bio equivalence study of Leuprolide acetate 30 mg in adult male subjects with advanced prostaticcancer undergoing initial therapy.CTRI/2020/10/028442Pharmathen SA32