Comparative bioavailability of the microemulsion formulation of cyclosporine (Neoral) with a generic dispersion formulation (Cicloral) in young healthy male volunteers

Therapeutic Drug Monitoring

Volumn 28, Issue 3, 2006, Pages 312-320

  Kees, Frieder ^a   Bucher, Michael ^a   Schweda, Frank ^a   Gschaidmeier, Harald ^b   Burhenne, Juergen ^c   Mikus, Gerd ^c   Faerber, Lothar ^a,b  

^a UNIVERSITY OF REGENSBURG   (Germany)

^b Novartis Pharma   (Germany)

^c Department of Internal Medicine VI Clinical Pharmacology and Pharmacoepidemiology ^*  (Germany)

Author keywords

Bioequivalence; Cyclosporine metabolites; Dextromethorphan; Pharmacokinetics; Phenotyping

Indexed keywords

CYCLOSPORIN A; CYTOCHROME P450 3A; DEXTROMETHORPHAN; DRUG METABOLITE; GENERIC DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; COMPARATIVE STUDY; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE CALCULATION; DOSE TIME EFFECT RELATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG HYDROXYLATION; DRUG METABOLISM; DRUG URINE LEVEL; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; METABOLIC CLEARANCE RATE; MICROEMULSION; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; VOLUNTEER;

ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CROSS-OVER STUDIES; CYCLOSPORINE; CYTOCHROME P-450 CYP2D6; CYTOCHROME P-450 CYP3A; DEXTROMETHORPHAN; DRUGS, GENERIC; EMULSIONS; HALF-LIFE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; METABOLIC CLEARANCE RATE; PHENOTYPE;

EID: 33748134253     PISSN: 01634356     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.ftd.0000211804.89440.74     Document Type: Article

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