Phase 1
Completed N=21
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Source: ClinicalTrials.gov NCT01795716 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose — 37256; 37206 mcg*hr/mL — p=<0.05
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose |
37256; 37206 | <0.05 sig |
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.
Data sourced from ClinicalTrials.gov (NCT01795716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.