Phase 1 clinical studies of oral garenoxacin in healthy Japanese adult subjects

Japanese Journal of Chemotherapy

Volumn 55, Issue SUPPL. 1, 2007, Pages 95-115

  Uchida, Eiji ^a  

^a SHOWA UNIVERSITY   (Japan)

Author keywords

Des fluro(6) quinolone; Garenoxacin; Pharmacokinetic; T 3811MEa

Indexed keywords

GARENOXACIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD PRESSURE MEASUREMENT; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG SAFETY; DRUG SCREENING; DRUG SENSITIVITY; DRUG TOLERABILITY; DRUG URINE LEVEL; ETHNIC DIFFERENCE; FEMALE; FOOD; FOOD DRUG INTERACTION; HUMAN; HUMAN EXPERIMENT; JAPANESE; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PROTEIN BINDING; SALIVA LEVEL; SINGLE DRUG DOSE; STEADY STATE; UNSPECIFIED SIDE EFFECT; URINARY EXCRETION;

EID: 35349016985     PISSN: 13407007     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. Randomized, double-blind, placebo-controlled, single-dose, dose-escalation study of the safety, tolerability and pharmacokinetics of BMS-284756 in healthy volunteers. Bristol-Myers Squibb. Final Study Report, 1999
2. Gajjar D A, Bello A, Ge Z, Christopher L, Grasela D M: Multiple-dose safety and pharmacokinetics of oral garenoxacin in healthy subjects. Antimicrob Agents Chemother 2003; 47: 2256-63
3. Randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study of the safety, tolerability, and pharmacokinetics of BMS-284756 in healthy subjects following 28-day oral dosing. Bristol-Myers Squibb. Clinical Study Report, 2002
4. Gajjar D A, Sukoneck S C, Bello A, Ge Z, Christopher L, Grasela D M: Effect of a high-fat meal on the pharmacokinetics of the des-F (6)-quinolone BMS-284756. Pharmacotherapy 2002; 22: 160-5
5. Guidance for industry, food-effect bioavailability and fed bioequivalence studies. Study design, data analysis, and labeling (Draft guidance). U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). October, 2001
6. Gabrielson J, Weiner D: Pharmacokinetic and pharmacodynamic data analysis: Concepts and applications, 2nd ed. Swedish Pharmaceutical Press, Stockholm, 1997
7. Japanese source.
8. Japanese source.
9. Japanese source.
10. Lister P D, Sanders C C: Pharmacodynamics of levofloxacin and ciprofloxacin against Streptococcus pneumoniae. J Antimicrob Chemother 1999; 43: 79-86
11. Preston S L, Drusano G L, Berman A L, Fowler C L, Chow A T, Dornseif B, et al: Pharmacodynamics of levofloxacin: a new paradigm for early clinical trials. JAMA 1998; 279: 125-9