Conditions: Chronic Myeloid Leukemia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 21
Healthy volunteers: no

Brief 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

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.

Arms:
arm 1: Single and multiple oral mesylate imatinib capsule 400mg qd arm 2: Single and multiple oral Glivec 400mg qd

Interventions: intervention 1: mesylate imatinib capsule intervention 2: Glivec
Intervention descriptions: intervention 1: Single and multiple oral mesylate imatinib capsule 400mg qd intervention 2: Single and multiple oral Glivec 400mg qd

Protocol document: