Clinical trial · Interventional
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
NCT01795716CI-TRIAL-00017946completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glivec | Drug | — | UNRESOLVED |
| mesylate imatinib capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mesylate imatinib capsule
- description
- Single and multiple oral mesylate imatinib capsule 400mg qd
- interventionNames
- Drug: mesylate imatinib capsule
- type
- ACTIVE_COMPARATOR
- label
- Glivec
- description
- Single and multiple oral Glivec 400mg qd
- interventionNames
- Drug: Glivec
Primary outcomes (1)
- measure
- Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose
- timeFrame
- predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.