Chronic Myeloid Leukemia Clinical Trial
Official title:
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Verified date | May 2015 |
Source | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
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 Stein AG).
2. Experimental Design: Two-period crossover design
3. Test drug: imatinib mesylate capsule Reference drug: Glivec
4. Sample size:20
Status | Completed |
Enrollment | 21 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Shanghai Jiaotong University School of Medicine Ruijin Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose | predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose | No |
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