Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

NCT01795716 | Completed Phase 1 Results DMC

• 1 other identifier: YMTN-1.0
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Experimental Design： Two-period crossover design
3. 3.Test drug: imatinib mesylate capsule Reference drug: Glivec
4. 4.Sample size：20

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

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

  predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose

Study Arms (2)

mesylate imatinib capsule

EXPERIMENTAL

Single and multiple oral mesylate imatinib capsule 400mg qd

Drug: mesylate imatinib capsule

Glivec

ACTIVE COMPARATOR

Single and multiple oral Glivec 400mg qd

Drug: Glivec

Interventions

mesylate imatinib capsule DRUG

Single and multiple oral mesylate imatinib capsule 400mg qd

Also known as: 111201

mesylate imatinib capsule

Glivec DRUG

Single and multiple oral Glivec 400mg qd

Also known as: Mesylate Imatinib tablet

Glivec

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic myeloid leukemia;
• Age: 18-65 years,gender:both.
• Weight: standard weight ± 20% within, and avoid weight disparity is too large;
• No previous radiation therapy, chemotherapy, or surgery within 1 weeks before treatment with imatinib;
• Performance status 0 to 3 (WHO scale); Life expectancy greater than 3 months;
• No other malignancy;
• Adequate hepatic, renal, and bone marrow function (WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥80×109/L. Serum bilirubin≤1.5×the institutional upper limit of normal, ALT、ALP≤2.5×the institutional upper limit of normal, creatinine≤1.5×the institutional upper limit of normal);
• Ability to understand objectives of the study, the study procedure, the pharmacological properties of the drug and possible adverse reactions and the willingness to sign a written informed consent.

You may not qualify if:

• Suffering from heart, liver, kidney disease or severe acute and chronic gastrointestinal diseases;
• Pregnant or lactating women and be sensitive to drug;
• Subjects are thought unsuitable for the study by investigators;
• Inability to comply with protocol or study procedures in the opinion of the investigator;
• Attending other clinical trials or attended other clinical trials 3 months ago.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Dr. Zhou Li
• Organization: Shanghai Jiaotong University School of Medicine Ruijin Hospital

lizhou999_999@yahoo.com

13816510379

Study Officials

• Shen Zh xiang, doctor

  Shanghai Jiaotong University School of Medicine Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 21, 2013
• Study Start: September 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 19, 2015
• Results First Posted: May 19, 2015

Record last verified: 2015-05

Locations

CN (1)