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Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

NCT01795716 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-05-19

Study results available
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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

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

mesylate imatinib capsule

Single and multiple oral mesylate imatinib capsule 400mg qd

DRUG

Glivec

Single and multiple oral Glivec 400mg qd

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shen Zh xiang, doctor · Shanghai Jiaotong University School of Medicine Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01795716 on ClinicalTrials.gov