Mycophenolate mofetil 500-mg tablet under fasting conditions: Single-dose, randomized-sequence, open-label, four-way replicate crossover, bioequivalence study in healthy subjects

Clinical Therapeutics

Volumn 32, Issue 3, 2010, Pages 556-574

  Almeida, Susana ^a,b   Filipe, Augusto ^a   Neves, Rita ^a   Spínola, Ana Cristina Franco ^a   Tanguay, Mario ^c   Ortuño, Jordi ^d   Farré, Anna ^d   Torns, Alex ^d  

^a Tecnimede Group   (Portugal)

^b UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^c SFBC Anapharm   (Canada)

^d Anapharm Europe SL   (Spain)

Author keywords

AUC; Bioequivalence; Cmax; MMF; MPA; Mycophenolate mofetil; Mycophenolic acid; Pharmacokinetic

Indexed keywords

GENERIC DRUG; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER;

ADULT; AREA UNDER THE CURVE; ARTICLE; BACKACHE; BIOEQUIVALENCE; BLOOD PRESSURE; CELLULITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; CYSTITIS; DIARRHEA; DIET RESTRICTION; DIZZINESS; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; ERYTHEMA; FATIGUE; FEMALE; HEART PALPITATION; HEART RATE; HERPES LABIALIS; HERPES SIMPLEX; HOT FLUSH; HUMAN; HUMAN EXPERIMENT; HYPESTHESIA; LEUKOCYTE COUNT; MALE; MAXIMUM PLASMA CONCENTRATION; MOUTH PAIN; MUSCULOSKELETAL PAIN; NAUSEA; NEURALGIA; NORMAL HUMAN; OPEN STUDY; PLASMA CONCENTRATION-TIME CURVE; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; RHINITIS; SIDE EFFECT; SINGLE DRUG DOSE; SKIN DEFECT; SOMNOLENCE; SORE THROAT; THORAX PAIN; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER ABDOMINAL PAIN;

ADMINISTRATION, ORAL; ADULT; ANALYSIS OF VARIANCE; AREA UNDER CURVE; CHROMATOGRAPHY, LIQUID; CROSS-OVER STUDIES; DRUG APPROVAL; DRUGS, GENERIC; EUROPE; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; PRODRUGS; TABLETS; TANDEM MASS SPECTROMETRY; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 77951944637     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.03.008     Document Type: Article

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