CompletedPhase 1

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

South Korea37 participantsStarted 2012-05

Plain-language 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

Who can participate

Age range20 Years – 50 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Maximum concentration in plasma (Cmax) of Imatinib mesylate

Timeframe: 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

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

Trial details

NCT IDNCT01751919

SponsorDong-A ST Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08

View on ClinicalTrials.gov More Chronic Myeloid Leukemia trials

Plain-language summary

Who can participate

Age range20 Years – 50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum concentration in plasma (Cmax) of Imatinib mesylate

Timeframe: 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

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