NCT01795716

Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	mesylate imatinib capsule	Single and multiple oral mesylate imatinib capsule 400mg qd
DRUG	Glivec	Single and multiple oral Glivec 400mg qd

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-02-21
• Last updated: 2015-05-19
• Results posted: 2015-05-19

Locations

1 site across 1 country: China