An innovative Phase I population pharmacokinetic approach to investigate the pharmacokinetics of an intranasal fentanyl spray in healthy subjects

International Journal of Clinical Pharmacology and Therapeutics

Volumn 51, Issue 6, 2013, Pages 495-508

  Plock, Nele ^a   Facius, Axel ^a   Hartmann, Lene ^b   Baumann, Sybille ^c   Nave, Rüdiger ^d  

^a Takeda Pharmaceuticals International GmbH   (Switzerland)

^b Takeda Denmark   (Denmark)

^c CRS Mannheim GmbH   (Germany)

^d Takeda Pharma GmbH   (Germany)

Author keywords

Breakthrough pain (BTP); Clinical trial design; Intranasal fentanyl spray (INFS); Population pharmacokinetics

Indexed keywords

FENTANYL;

ADULT; AREA UNDER THE CURVE; ARTICLE; BREAKTHROUGH PAIN; CANCER PAIN; CANCER PATIENT; CLINICAL ARTICLE; CONTROLLED STUDY; COST CONTROL; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; FEMALE; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; PHASE 1 CLINICAL TRIAL; SINGLE DRUG DOSE;

ADMINISTRATION, INTRANASAL; ADOLESCENT; ADULT; ANALGESICS, OPIOID; BREAKTHROUGH PAIN; COMPUTER SIMULATION; CROSS-OVER STUDIES; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FENTANYL; HUMANS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NASAL SPRAYS; RESEARCH DESIGN; TIME FACTORS; YOUNG ADULT;

EID: 84878791263     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CP201867     Document Type: Article

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