Relative bioavailability of sapropterin from intact and dissolved sapropterin dihydrochloride tablets and the effects of food: A randomized, open-label, crossover study in healthy adults

Clinical Therapeutics

Volumn 32, Issue 2, 2010, Pages 338-346

  Musson, Donald G ^a   Kramer, William G ^b   Foehr, Erik D ^a   Bieberdorf, Frederick A ^c   Hornfeldt, Carl S ^a   Kim, Sun Sook ^a   Dorenbaum, Alex ^a  

^a BIOMARIN PHARMACEUTICAL INC   (United States)

^b Kramer Consulting LLC   (United States)

^c CEDRA Clinical Research LLC   (United States)

Author keywords

bioavailability; pharmacokinetics; phenylketonuria; sapropterin; tetrahydrobiopterin

Indexed keywords

KUVAN; SAPROPTERIN; TETRAHYDROBIOPTERIN; UNCLASSIFIED DRUG;

ADULT; AFRICAN AMERICAN; AMERICAN INDIAN; AREA UNDER THE CURVE; ARTICLE; ASIAN; BLOOD SAMPLING; CALORIC INTAKE; CAUCASIAN; CENTRAL NERVOUS SYSTEM DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE SEVERITY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM COMPARISON; DRUG ELIMINATION; DRUG FATALITY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAM; FEMALE; FOLLOW UP; FOOD; FOOD DRUG INTERACTION; GASTROINTESTINAL DISEASE; HISPANIC; HUMAN; HUMAN EXPERIMENT; LABORATORY TEST; LIPID DIET; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; PACIFIC ISLANDER; PHYSICAL EXAMINATION; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION; VITAL SIGN;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; BIOPTERIN; CROSS-OVER STUDIES; DIETARY FATS; ENERGY INTAKE; FASTING; FEMALE; FOOD-DRUG INTERACTIONS; HUMANS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; POSTPRANDIAL PERIOD; SOLUBILITY; TABLETS; YOUNG ADULT;

EID: 77649092426     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.02.012     Document Type: Article

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