A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)

NCT01751919 | Completed Phase 1

• 1 other identifier: Imatinib_CML_I
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Investigational Product
2. 2.Imatinib mesylate tablet 400 mg
3. 3.Glivec film-coated tablet 100 mg (Comparator)
4. 4.Expected target disease
5. 5.chronic myeloid leukemia
6. 6.Gastrointestinal stromal tumors
7. 7.Study design : Randomized, open-label, single dose, two-period, two-way, crossover study
8. 8.36 healthy subjects, 2 groups (18 subjects/group)
9. 9.2 Period (either 1-a(1 tablet) or 1-b(4 tablet))
10. 10.wash-out period : 14 days
11. 11.Evaluation on pharmacokinetics(PKs) and safety
12. 12.PKs : Cmax, AUClast, Tmax, AUCinf, t1/2
13. 13.safety : adverse events, physical examination, vital sign, ECG, Laboratory test
14. 14.Statistical method
15. 15.Demography Characteristics
16. 16.Pharmacokinetic parameters
17. 17.Safety data

Conditions

Chronic Myeloid Leukemia; Gastrointestinal Stromal Tumor

Keywords

CML; GIST

Outcome Measures

Primary Outcomes (2)

• Maximum concentration in plasma (Cmax) of Imatinib mesylate

  Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose

• Area under the plasma concentration-time curve from zero time until the last measurable concentration (AUClast) of Imatinib mesylate

  Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose

Secondary Outcomes (3)

• Time to Cmax (Tmax) of Imatinib mesylate

  Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose

• Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of Imatinib mesylate

  Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose

• Terminal Elimination Half-life (t1/2) of Imatinib mesylate

  Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose

Study Arms (2)

Group 1 (RT)

OTHER

* Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator) * Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)

Drug: Imatinib mesylate tablet 400 mg, 1 Tablet; Drug: Glivec film-coated tablet 100 mg, 4 Tablets

Group 2 (TR)

OTHER

* Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental) * Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)

Drug: Imatinib mesylate tablet 400 mg, 1 Tablet; Drug: Glivec film-coated tablet 100 mg, 4 Tablets

Interventions

Imatinib mesylate tablet 400 mg, 1 Tablet DRUG

Group 1 (RT); Group 2 (TR)

Glivec film-coated tablet 100 mg, 4 Tablets DRUG

Group 1 (RT); Group 2 (TR)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male volunteers between the ages of 20 to 50 years old
• weight more than 55kg and within the range of ±20% of ideal body weight (IBW)
• having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
• doctor determines to be suitable as subjects within 3 weeks ago before administration

You may not qualify if:

• Hypersensitivity(or history of hypersensitivity) to medicines including imatinib mesylate
• Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
• Creatinine clearance \< 80 mL/min
• Gastrointestinal diseases or surgeries that affect absorption of drug
• Excessive drinking(exceed 21units/week)
• Smoking over 10 cigarettes per day

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Kyungpook National University

Daegu, South Korea

Location

Related Publications (2)

• Parrillo-Campiglia S, Ercoli MC, Umpierrez O, Rodriguez P, Marquez S, Guarneri C, Estevez-Parrillo FT, Laurenz M, Estevez-Carrizo FE. Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers. Clin Ther. 2009 Oct;31(10):2224-32. doi: 10.1016/j.clinthera.2009.10.009.

  PMID: 19922893 BACKGROUND

• Nikolova Z, Peng B, Hubert M, Sieberling M, Keller U, Ho YY, Schran H, Capdeville R. Bioequivalence, safety, and tolerability of imatinib tablets compared with capsules. Cancer Chemother Pharmacol. 2004 May;53(5):433-8. doi: 10.1007/s00280-003-0756-z.

  PMID: 15132131 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Gastrointestinal Stromal Tumors

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; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

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

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: December 14, 2012
• First Posted: December 18, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

KR (1)