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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01795716
Other study ID # YMTN-1.0
Secondary ID
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


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
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