Safety and tolerability of serelaxin, a recombinant human relaxin-2 in development for the treatment of acute heart failure, in healthy Japanese volunteers and a comparison of pharmacokinetics and pharmacodynamics in healthy Japanese and Caucasian populations

Journal of Clinical Pharmacology

Volumn 55, Issue 4, 2015, Pages 415-422

  Dahlke, Marion ^a   Ng, Dik ^b   Yamaguchi, Masayuki ^c   Machineni, Surendra ^d   Berger, Sergej ^e   Canadi, Jasna ^a   Rajman, Iris ^a   Lloyd, Peter ^b   Pang, Yinuo ^f  

^a NOVARTIS PHARMA AG   (Switzerland)

^b Novartis Pharma UKWest Sussex   (United Kingdom)

^c NOVARTIS PHARMA K K   (Japan)

^d Novartis India Limited   (India)

^e Focus Clinical Drug Development GmbH   (Germany)

^f NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

Author keywords

cardiovascular; clinical pharmacology; clinical trials; pharmacodynamics; pharmacokinetics and drug metabolism

Indexed keywords

C REACTIVE PROTEIN; PLACEBO; SERELAXIN; CHLORIDE; CREATININE; POTASSIUM; RECOMBINANT PROTEIN; RELAXIN; SERELAXIN PROTEIN, HUMAN; SODIUM; UREA;

ACUTE HEART FAILURE; ADULT; AREA UNDER THE CURVE; ARTICLE; CAUCASIAN; CLINICAL ARTICLE; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPISTAXIS; ETHNICITY; FATIGUE; FEMALE; GLOMERULUS FILTRATION RATE; HUMAN; HYPESTHESIA; JAPANESE (PEOPLE); MALE; NONCARDIAC CHEST PAIN; OPEN STUDY; PERIODONTITIS; POSITIONAL DIZZINESS; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; RHINITIS; SIDE EFFECT; SOMNOLENCE; STEADY STATE; TOOTH ABSCESS; TOOTH PAIN; UPPER ABDOMINAL PAIN; VOLUNTEER; ACUTE DISEASE; ASIAN CONTINENTAL ANCESTRY GROUP; BLOOD; COMPARATIVE STUDY; DOSE RESPONSE; HEART FAILURE; HEMATOCRIT; JAPAN; NORMAL HUMAN; OSMOLARITY; PATIENT SAFETY; URINE; YOUNG ADULT;

ACUTE DISEASE; ADULT; ASIAN CONTINENTAL ANCESTRY GROUP; CHLORIDES; CREATININE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; HEALTHY VOLUNTEERS; HEART FAILURE; HEMATOCRIT; HUMANS; JAPAN; MALE; OSMOLAR CONCENTRATION; PATIENT SAFETY; POTASSIUM; RECOMBINANT PROTEINS; RELAXIN; SODIUM; UREA; YOUNG ADULT;

EID: 84924354928     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.433     Document Type: Article

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