Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

Chronic Myeloid Leukemia Clinical Trial

Official title:

Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795716
• Other study ID #: YMTN-1.0
• Status: Completed
• Phase: Phase 1
• First received: February 6, 2013
• Last updated: May 16, 2015
• Start date: September 2012
• Est. completion date: June 2013

Study information

• Verified date: May 2015
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• mesylate imatinib capsule
Single and multiple oral mesylate imatinib capsule 400mg qd
• Glivec
Single and multiple oral Glivec 400mg qd

Locations

Country	Name	City	State
China	Shanghai Jiaotong University School of Medicine Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No