Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

NCT ID: NCT01795716

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-06-30

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 Stein AG).

2. Experimental Design： Two-period crossover design

3. Test drug: imatinib mesylate capsule Reference drug: Glivec

4. Sample size：20

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

Conditions

Chronic Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mesylate imatinib capsule

Single and multiple oral mesylate imatinib capsule 400mg qd

Group Type: EXPERIMENTAL

mesylate imatinib capsule

Intervention Type: DRUG

Single and multiple oral mesylate imatinib capsule 400mg qd

Glivec

Single and multiple oral Glivec 400mg qd

Group Type: ACTIVE_COMPARATOR

Glivec

Intervention Type: DRUG

Single and multiple oral Glivec 400mg qd

Interventions

mesylate imatinib capsule

Single and multiple oral mesylate imatinib capsule 400mg qd

Intervention Type: DRUG

Glivec

Single and multiple oral Glivec 400mg qd

Intervention Type: DRUG

Other Intervention Names

111201; Mesylate Imatinib tablet

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shen Zh xiang, doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Locations

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, , China

Countries

China

Other Identifiers

YMTN-1.0

Identifier Type: -

Identifier Source: org_study_id