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

Clinical Therapeutics

Volumn 31, Issue 10, 2009, Pages 2224-2232

  Parrillo Campiglia, Susana ^a,b   Ercoli, Mónica Cedres ^a   Umpierrez, Ofelia ^a   Rodríguez, Patricia ^a   Márquez, Sara ^a   Guarneri, Carolina ^a   Estevez Parrillo, Francisco T ^a   Laurenz, Marilena ^a   Estevez Carrizo, Francisco E ^a,b  

^a Hospital Italiano Montevideo   (Uruguay)

^b UNIVERSIDAD DE MONTEVIDEO   (Uruguay)

Author keywords

bioavailability; bioequivalence; chronic myelogenous leukemia; gastrointestinal stromal tumor; imatinib mesylate

Indexed keywords

GENERIC DRUG; IBUPROFEN; IMATINIB;

ADULT; AGE DISTRIBUTION; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BODY HEIGHT; BODY MASS; BODY WEIGHT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEMOGRAPHY; DIARRHEA; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG ELIMINATION; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; DRUG URINE LEVEL; FILM COATING; FOLLOW UP; HUMAN; HUMAN EXPERIMENT; LABORATORY TEST; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; OPEN STUDY; PHYSICAL EXAMINATION; POPULATION RESEARCH; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SOUTH AMERICA; SYMPTOMATOLOGY; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION; URUGUAY; VITAL SIGN; VOLUNTEER; VOMITING;

ADOLESCENT; ADULT; ANALYSIS OF VARIANCE; ANTINEOPLASTIC AGENTS; ARGENTINA; BODY MASS INDEX; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CROSS-OVER STUDIES; HUMANS; MALE; MIDDLE AGED; MODELS, STATISTICAL; PIPERAZINES; PYRIMIDINES; QUALITY CONTROL; SPECTROPHOTOMETRY, ULTRAVIOLET; THERAPEUTIC EQUIVALENCY; URUGUAY; YOUNG ADULT;

EID: 71549153468     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.10.009     Document Type: Article

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