Bioequivalence of single 100-mg doses of two oral formulations of topiramate: An open-label, randomized-sequence, two-period crossover study in healthy adult male Mexican volunteers

Clinical Therapeutics

Volumn 31, Issue 2, 2009, Pages 411-417

  Piñeyro López, Alfredo ^a   Piñeyro Garza, Everardo ^a   Gómez Silva, Magdalena ^a   Reyes Araiza, Raúl ^a   Flores Diego, Marco A ^a   Borrego Alvarado, Salvador ^a   Gamino Peña, María E ^a   Vargas Zapata, Rigoberto ^a   Salazar Leal, Martha E ^a  

^a Ipharma SA de CV   (Mexico)

Author keywords

bioavailability; bioequivalence; human; mass spectrometry; pharmacokinetics; topiramate

Indexed keywords

GENERIC DRUG; TOPIRAMATE;

ABSENCE OF SIDE EFFECTS; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD CHEMISTRY; BLOOD PRESSURE MONITORING; BLOOD SAMPLING; BODY TEMPERATURE MEASUREMENT; BREATHING RATE; CLINICAL LABORATORY; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG DOSAGE FORM COMPARISON; DRUG TOLERABILITY; HEART RATE; HEMATOLOGICAL PARAMETERS; HUMAN; HUMAN EXPERIMENT; INTERVIEW; LABORATORY TEST; LIVER FUNCTION; MALE; MAXIMUM PLASMA CONCENTRATION; MEXICO; NORMAL HUMAN; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STUDENT T TEST; TIME TO MAXIMUM PLASMA CONCENTRATION; URINALYSIS; VITAL SIGN; VOLUNTEER;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; ANTICONVULSANTS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DRUGS, GENERIC; FRUCTOSE; HUMANS; MALE; MEXICO; TABLETS; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 62149104040     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.02.001     Document Type: Article

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