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Pharmacology

Pharmacokinetics and Tolerability of Gemifloxacin (SB-265805) after Administration of Single Oral Doses to Healthy Volunteers

Ann Allen, Elizabeth Bygate, Stuart Oliver, Martin Johnson, Christopher Ward, Ae-Jin Cheon, Youn Sung Choo, In-Chull Kim
Ann Allen
Drug Metabolism and Pharmacokinetics, SmithKline Beecham Pharmaceuticals, Welwyn, Hertfordshire,
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Elizabeth Bygate
Clinical Pharmacology Department, SmithKline Beecham Pharmaceuticals, Harlow, Essex, and
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Stuart Oliver
Covance, Leeds, United Kingdom, and
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Martin Johnson
Covance, Leeds, United Kingdom, and
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Christopher Ward
Covance, Leeds, United Kingdom, and
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Ae-Jin Cheon
Clinical Drug Development and
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Youn Sung Choo
Clinical Drug Development and
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In-Chull Kim
Drug Evaluation and Development, Biotech Research Institute, LG Chemicals Research Park, Taejon, South Korea
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DOI: 10.1128/AAC.44.6.1604-1608.2000
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ABSTRACT

Gemifloxacin (known as SB-265805 or LB-20304) is a potent, novel fluoroquinolone compound with a broad spectrum of antibacterial activity. The pharmacokinetics and tolerability of oral gemifloxacin were characterized in healthy male volunteers after a single dose of 20, 40, 80, 160, 320, 600, or 800 mg. Multiple serum and urine samples were collected and analyzed for gemifloxacin using high-performance liquid chromatography with fluorescence detection. Safety assessments included vital signs, 12-lead electrocardiogram readings, hematology, clinical chemistry, urinalysis, and adverse-experience monitoring. Gemifloxacin was rapidly absorbed after all doses. Maximum concentrations of gemifloxacin in serum (Cmax) were achieved approximately 1 h after dosing, after which concentrations in serum declined in a biexponential manner. Values ofCmax and the area under the concentration-time curve in serum from 0 h to infinity (serum AUC0–∞) increased linearly with dose. Serum AUC0–∞ values (mean ± standard deviation) were 0.65 ± 0.01, 1.28 ± 0.22, 2.54 ± 0.31, 5.48 ± 1.24, 9.82 ± 2.70, 24.4 ± 7.1, and 31.4 ± 7.6 μg · h/ml following 20-, 40-, 80-, 160-, 320-, 600-, and 800-mg doses, respectively. The terminal phase elimination half-life was independent of dose, with an overall mean of 7.4 ± 2.0 h. The profiles indicated that the pharmacokinetic profile is suitable for a once-daily dosing regimen. Approximately 25 to 40% of the administered dose was excreted unchanged in the urine, and renal clearance (ca. 150 ml/min) was independent of dose. There were no significant changes in clinical chemistry, hematology, or urinalysis parameters, vital signs, or 12-lead electrocardiogram readings in subjects, irrespective of dose. The results of these studies support the further investigation of once-daily administration of gemifloxacin.

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Pharmacokinetics and Tolerability of Gemifloxacin (SB-265805) after Administration of Single Oral Doses to Healthy Volunteers
Ann Allen, Elizabeth Bygate, Stuart Oliver, Martin Johnson, Christopher Ward, Ae-Jin Cheon, Youn Sung Choo, In-Chull Kim
Antimicrobial Agents and Chemotherapy Jun 2000, 44 (6) 1604-1608; DOI: 10.1128/AAC.44.6.1604-1608.2000

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Pharmacokinetics and Tolerability of Gemifloxacin (SB-265805) after Administration of Single Oral Doses to Healthy Volunteers
Ann Allen, Elizabeth Bygate, Stuart Oliver, Martin Johnson, Christopher Ward, Ae-Jin Cheon, Youn Sung Choo, In-Chull Kim
Antimicrobial Agents and Chemotherapy Jun 2000, 44 (6) 1604-1608; DOI: 10.1128/AAC.44.6.1604-1608.2000
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KEYWORDS

anti-infective agents
fluoroquinolones
Naphthyridines

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