Spots Global Cancer Trial Database for Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
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Trial Identification
Brief Title: Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Official Title: Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Study ID: NCT01795716
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai, , China
Contact Details
Name: Shen Zh xiang, doctor
Affiliation: Shanghai Jiaotong University School of Medicine Ruijin Hospital
Role: PRINCIPAL_INVESTIGATOR
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