CTRI/2014/03/004484已完成未知
A randomized, open label, two treatment, two sequence, steady-state crossover bioequivalence study of imatinib mesylate 400 mg tablet of Sun Pharmaceutical Industries Limited, India and Gleevec (Imatinib mesylate) 400 mg tablets of Novartis Pharmaceuticals Corporation, administered under fed conditions in chronic myeloid leukemia (CML) patients
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 36
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
- •i. Availability of subject for the entire study period and willingness to adhere to protocol
- •requirements.
- •ii. Patients between 18 to 60 years of age.
- •iii. Patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia
- •(Ph+ CML) in chronic phase
- •iv. Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in
- •chronic phase after failure of interferon-alpha therapy.
- •v. Subjects with Performance <= 2 on the ECOG performance scale (listed in Appendix III).
- •vi. Subjects who have no evidence of underlying disease which in the judgment of the
- •investigator would not make the subject inappropriate for getting enrolled in the study (except
- •CML) during screening, medical history and whose physical examination is performed within
- •21 days prior to commencement of the study.
- •vii. Subjects whose screening laboratory values are within normal limits or considered by the
- •Investigator/sub-Investigator to be of no clinical significance.
- •viii. Informed consent form given in written form according to section 9.3 of the protocol.
- •ix. Female Subjects
- •of child bearing potential practicing an acceptable method of birth control for the
- •duration of the study as judged by the investigator(s), such as condoms, foams, jellies,
- •diaphragm, intrauterine device (IUD), or abstinence.
- •Postmenopausal for at least 1 year.
- •surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has
- •been performed on the subject)
排除标准
- •1. History or presence of significant:
- •Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Imatinib Mesylate
- •and/or any related compounds etc.
- •Cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,
- •dermatologic, musculoskeletal, neurological or psychiatric disease which has an impact on
- •subject safety and does not permit dosing of imatinib.
- •Use of following drugs as concurrent therapy:
- •Erythromycin, warfarin, CYP inhibitors (e.g. ketoconazole, itraconazole, clarithromycin,
- •atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin,
- •voriconazole) or CYP inducers (e.g. dexamethasone, phenytoin, carbamazepine,
- •oxcarbazepine, rifampicin, rifabutin, Rifampin, phenobarbital, fosphenytoin, primidone or
- •Hypericum perforatum, also known as St. Johns Wort, Griseofulvin).
- •Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within
- •past one year.
- •Smoking (>= 10 cigarettes/day) or consumption of tobacco products (>= 4 chews/day).
- •History of difficulty in swallowing or coming for follow up.
- •Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks
- •preceding the study
- •Female subject who is pregnant, lactating or likely to become pregnant or have a positive
- •pregnancy test at screening and prior to study.
- •Positive result to HIV, HCV, RPR and HBsAg.
- •Abnormal 12 lead ECG, X-ray.
- •2 Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study
- •3 Participation in another clinical trial within the preceding 90 days of study starts.
- •4 Subjects who have:
- •Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
- •Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor
- •deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the investigator.
- •Pulse rate below 60/min. or above 100/min.
研究者
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