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

Chronic Myeloid Leukemia Clinical Trial

Official title:

A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400 mg (1 Tablet) and Glivec Film-coated Tablet 100 mg (4 Tablets) After Oral Administration in Healthy Male Subjects (Phase I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751919
• Other study ID #: Imatinib_CML_I
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2012
• Last updated: September 29, 2014
• Start date: May 2012
• Est. completion date: August 2012

Study information

• Verified date: September 2014
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea : Korea Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

1. Investigational Product

1. Imatinib mesylate tablet 400 mg

2. Glivec film-coated tablet 100 mg (Comparator)

2. Expected target disease

1. chronic myeloid leukemia

2. Gastrointestinal stromal tumors

3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study

1. 36 healthy subjects, 2 groups (18 subjects/group)

2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))

3. wash-out period : 14 days

4. Evaluation on pharmacokinetics(PKs) and safety

1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2

2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test

5. Statistical method

1. Demography Characteristics

2. Pharmacokinetic parameters

3. Safety data

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention

Drug:
• Imatinib mesylate tablet 400 mg, 1 Tablet

• Glivec film-coated tablet 100 mg, 4 Tablets

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

Parrillo-Campiglia S, Ercoli MC, Umpierrez O, Rodríguez P, Márquez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No