Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

Study Overview
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Brief Summary
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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). Experimental Design： Two-period crossover design Test drug: imatinib mesylate capsule Reference drug: Glivec Sample size：20

Detailed Description
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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.

Official Title
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Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

Conditions
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Chronic Myeloid Leukemia

Intervention / Treatment
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* Drug: mesylate imatinib capsule
* Drug: Glivec


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesylate imatinib capsule<br>Single and multiple oral mesylate imatinib capsule 400mg qd | Drug: mesylate imatinib capsule<br>* Single and multiple oral mesylate imatinib capsule 400mg qd<br>* Other names: 111201;|
| Active Comparator: Glivec<br>Single and multiple oral Glivec 400mg qd | Drug: Glivec<br>* Single and multiple oral Glivec 400mg qd<br>* Other names: Mesylate Imatinib tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |