At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
mesylate imatinib capsule +1 moredrug
Likely dose
mesylate imatinib capsule 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·interventional·Posted Feb 21, 2013·Updated May 19, 2015
In Brief
A Phase 1 clinical trial evaluating mesylate imatinib capsule and Glivec for Chronic Myeloid Leukemia. Completed, enrolled 21 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloid Leukemia
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2012
First PostedFeb 2013
Primary CompletionJun 2013
TodayJul 2026
First PostedFeb 21, 2013
Enrollment StartSep 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.4 years ago
Interventions
mesylate imatinib capsuledrug
Single and multiple oral mesylate imatinib capsule 400mg qd
Glivecdrug
Single and multiple oral Glivec 400mg qd