Single-Dose Bioequivalence of 105-mg Fenofibric Acid Tablets Versus 145-mg Fenofibrate Tablets Under Fasting and Fed Conditions: A Report of Two Phase I, Open-Label, Single-Dose, Randomized, Crossover Clinical Trials

Clinical Therapeutics

Volumn 33, Issue 6, 2011, Pages 766-775

  Godfrey, Anthony R ^a   DiGiacinto, Jennifer ^b   Davis, Matthew W ^c  

^a PRACS Institute Ltd   (United States)

^b Salamandra LLC   (United States)

^c Mutual Pharmaceutical Company Inc   (United States)

Author keywords

Administration; Bioequivalence; Clinical trials as topic; Fenofibric acid; Hyperlipidemias blood drug therapy; Oral

Indexed keywords

FENOFIBRATE; FENOFIBRIC ACID;

ADULT; ARTICLE; ASIAN; BIOEQUIVALENCE; BODY WEIGHT; CAUCASIAN; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DIZZINESS; DRUG SAFETY; DRUG TOLERABILITY; DRY THROAT; FEMALE; HEADACHE; HUMAN; HUMAN EXPERIMENT; LABORATORY TEST; MALE; MAXIMUM PLASMA CONCENTRATION; NEGRO; NORMAL HUMAN; PHYSICAL EXAMINATION; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; UNITED STATES; VITAL SIGN;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; ANTICHOLESTEREMIC AGENTS; AREA UNDER CURVE; CROSS-OVER STUDIES; DIETARY FATS; FASTING; FEMALE; FENOFIBRATE; FOOD-DRUG INTERACTIONS; HUMANS; MALE; PRODRUGS; TABLETS; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 79959486098     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2011.05.047     Document Type: Article

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