Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

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

Study Overview

• Status: Completed
• Conditions: Chronic Myeloid Leukemia
• Intervention / Treatment: Drug: mesylate imatinib capsule; Drug: Glivec

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200025
    • Shanghai Jiaotong University School of Medicine Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: mesylate imatinib capsule; Single and multiple oral mesylate imatinib capsule 400mg qd	Drug: mesylate imatinib capsule; Single and multiple oral mesylate imatinib capsule 400mg qd; Other Names: 111201
ACTIVE_COMPARATOR: Glivec; Single and multiple oral Glivec 400mg qd	Drug: Glivec; Single and multiple oral Glivec 400mg qd; Other Names: Mesylate Imatinib tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Investigators: Principal Investigator: Shen Zh xiang, doctor, Shanghai Jiaotong University School of Medicine Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 18, 2013
• First Posted (ESTIMATE): February 21, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 19, 2015
• Last Update Submitted That Met QC Criteria: May 16, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: YMTN-1.0