Back to resultsBioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Primary Purpose
Chronic Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
mesylate imatinib capsule
Glivec
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia
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.
Sites / Locations
- Shanghai Jiaotong University School of Medicine Ruijin Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mesylate imatinib capsule
Glivec
Arm Description
Single and multiple oral mesylate imatinib capsule 400mg qd
Single and multiple oral Glivec 400mg qd
Outcomes
Primary Outcome Measures
Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose
Secondary Outcome Measures
Full Information
NCT ID
NCT01795716
First Posted
February 6, 2013
Last Updated
May 16, 2015
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01795716
Brief Title
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Official Title
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mesylate imatinib capsule
Arm Type
Experimental
Arm Description
Single and multiple oral mesylate imatinib capsule 400mg qd
Arm Title
Glivec
Arm Type
Active Comparator
Arm Description
Single and multiple oral Glivec 400mg qd
Intervention Type
Drug
Intervention Name(s)
mesylate imatinib capsule
Other Intervention Name(s)
111201
Intervention Description
Single and multiple oral mesylate imatinib capsule 400mg qd
Intervention Type
Drug
Intervention Name(s)
Glivec
Other Intervention Name(s)
Mesylate Imatinib tablet
Intervention Description
Single and multiple oral Glivec 400mg qd
Primary Outcome Measure Information:
Title
Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose
Time Frame
predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Zh xiang, doctor
Organizational Affiliation
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Jiaotong University School of Medicine Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Learn more about this trial
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
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