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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01751919
Other study ID # Imatinib_CML_I
Secondary ID
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


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
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