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Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

Phase 1
18 Years
65 Years
Open (Enrolling)
Chronic Myeloid Leukemia

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Trial Information

Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

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 compare the bioequivalence and pharmacokinetics of the two
products in 20 patients with chronic myeloid leukemia.

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

- Attending other clinical trials or attended other clinical trials 3 months ago.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Area Under Curve (AUC) Time Frame: predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose

Outcome Time Frame:

9 months

Safety Issue:


Principal Investigator

Shen Zh xiang, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Jiaotong University School of Medicine Ruijin Hospital


China: Ethics Committee

Study ID:




Start Date:

September 2012

Completion Date:

June 2013

Related Keywords:

  • Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive