Status:
COMPLETED
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
1. purpose: To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma ...
Detailed Description
To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule(Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG) and...
Eligibility Criteria
Inclusion
- Patients with chronic myeloid leukemia;
- Age: 18-65 years,gender:both.
- Weight: standard weight ± 20% within, and avoid weight disparity is too large;
- No previous radiation therapy, chemotherapy, or surgery within 1 weeks before treatment with imatinib;
- Performance status 0 to 3 (WHO scale); Life expectancy greater than 3 months;
- No other malignancy;
- Adequate hepatic, renal, and bone marrow function (WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥80×109/L. Serum bilirubin≤1.5×the institutional upper limit of normal, ALT、ALP≤2.5×the institutional upper limit of normal, creatinine≤1.5×the institutional upper limit of normal);
- Ability to understand objectives of the study, the study procedure, the pharmacological properties of the drug and possible adverse reactions and the willingness to sign a written informed consent.
Exclusion
- Suffering from heart, liver, kidney disease or severe acute and chronic gastrointestinal diseases;
- Pregnant or lactating women and be sensitive to drug;
- Subjects are thought unsuitable for the study by investigators;
- Inability to comply with protocol or study procedures in the opinion of the investigator;
- Attending other clinical trials or attended other clinical trials 3 months ago.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01795716
Start Date
September 1 2012
End Date
June 1 2013
Last Update
May 19 2015
Active Locations (1)
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1
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, China, 200025