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Myeloid Leukemia

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Imatinib Mesylate

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Single and multiple oral mesylate imatinib capsule 400mg qd

mesylate imatinib capsule

Glivec

Shen Zh xiang, doctor

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

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.

Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule

Mesylate Imatinib Capsule

Subjects were assigned to receive a single and multiple 400 mg oral dose Glivec

Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period. In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .

Mesylate Imatinib Capsule First, Then Glivec

Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .

Glivec First, Then Mesylate Imatinib Capsule

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

China

Region of Enrollment

Dr. Zhou Li

The 90% confidence intervals of the test/reference ratios for AUC0-∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.

Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule

Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Glivec

Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose

Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period.In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .

First Intervention (13 Days)

Washout (10 Days)

Second Intervention (13 Days)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body	NCT01795716	Chronic Myeloid...	mesylate imatin... Glivec	18 Years - 65 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body	NCT01795716	Chronic Myeloid...	mesylate imatin... Glivec	18 Years - 65 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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