Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

CTTQ

Status and phase: Completed; Phase 1

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: mesylate imatinib capsule; Drug: Glivec

Study type: Interventional

Funder types: Industry

Identifiers

NCT01795716

YMTN-1.0

Details and patient eligibility

About

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

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

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

mesylate imatinib capsule

Experimental group

Description:

Single and multiple oral mesylate imatinib capsule 400mg qd

Treatment:

Drug: mesylate imatinib capsule

Glivec

Active Comparator group

Description:

Single and multiple oral Glivec 400mg qd

Treatment:

Drug: Glivec