The effect of food on the bioavailability of oral gemifloxacin in healthy volunteers

Allen, Ann; Bygate, Elizabeth; Clark, Darren; Lewis, Anastasia; Pay, V.

doi:10.1016/s0924-8579(00)00181-3

Cited by 24 publications

(8 citation statements)

References 10 publications

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“…In clinical trials with male and female healthy volunteers and patients, gemifloxacin has been well tolerated. In 12 phase I trials investigating gemifloxacin pharmacokinetics and drug interactions, a total of 268 healthy volunteers were administered oral doses (single or multiple) of gemifloxacin 20-800 mg, most often 320 mg. [53][54][55][56][57][107][108][109][110][111][112][113] In these studies, the frequency of adverse events was low, most adverse events were of mild-to-moderate severity, and there were no reports of any serious adverse events that were suspected to be, or probably were, related to gemifloxacin therapy. The most commonly reported adverse events either suspected to be or probably gemifloxacin related were headache, diarrhea, nausea, and rash.…”

Section: Safety Considerationsmentioning

confidence: 93%

“…53,54 One study examined the effect of food on the bioavailability of single oral doses of gemifloxacin in 20 healthy volunteers (13 men, 7 women). 57 Compared with the fasting state, the C max and AUC 0-∞ of oral doses of gemifloxacin administered after a high-fat meal were reduced by 12% (95% CI 0.76-1.02) and 3% (95% CI 0.88-1.07) for the 320-mg dose, and 14% (95% CI 0.75-1.00) and 12% (95% CI 0.79-0.97) for the 640-mg dose, respectively. The effect of food on T max was minimal, delaying the T max by, on average, less than an hour for each dose strength.…”

Section: Pharmacokineticsmentioning

confidence: 99%

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Gemifloxacin for the Treatment of Respiratory Tract Infections: In Vitro Susceptibility, Pharmacokinetics and Pharmacodynamics, Clinical Efficacy, and Safety

Bhavnani

Andes

2005

Pharmacotherapy

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Gemifloxacin is a synthetic fluoroquinolone antimicrobial agent exhibiting potent activity against most gram-negative and gram-positive organisms, such as the important community-acquired respiratory pathogens Streptococcus pneumoniae (including multidrug-resistant S. pneumoniae), Haemophilus influenzae , and Moraxella catarrhalis . The agent's mechanism of action involves dual targeting of two essential bacterial enzymes: DNA gyrase and topoisomerase IV. Gemifloxacin was approved by the Food and Drug Administration in April 2003 for treatment of community-acquired pneumonia and acute bacterial exacerbation of chronic bronchitis. The drug has an oral bioavailability of approximately 71%. Approximately 20-35% of gemifloxacin is excreted unchanged in the urine after 24 hours. The elimination half-life of gemifloxacin is 6-8 hours in patients with normal renal function, supporting once-daily dosing. The 24-hour free-drug area under the plasma concentration-time curve:minimum inhibitory concentration ratio (fAUC(0-24):MIC) associated with efficacy, based on results from in vitro and animal models of infection, is approximately 30. With a mean fAUC(0-24) of approximately 3 microg*hour/ml (35% of total AUC(0-24) of 8.4) and a median S. pneumoniae MIC for 90% of tested strains of 0.03, a fAUC(0-24):MIC ratio of 100 would be expected after standard dosing (320 mg once/day). In clinical studies involving both hospitalized and outpatient populations, gemifloxacin has been highly effective in the treatment of community-acquired pneumonia and acute exacerbation of chronic bronchitis. Clinical success rates ranged from 93.9-95.9% in patients with community-acquired pneumonia and 96.1-97.5% in those with acute exacerbation of chronic bronchitis. Gemifloxacin is well tolerated; the frequency of adverse events with this agent is low. Most adverse events are mild-to-moderate in severity, with diarrhea (< 4%), nausea and rash (< 3%), and headache (< 2%) most commonly reported. Drug interactions with gemifloxacin are not common, although absorption is greatly reduced when given with divalent and trivalent cation-containing compounds, such as antacids. Due to its potent activity against many common gram-positive and gram-negative respiratory pathogens, its proven clinical efficacy, and its favorable safety profile, gemifloxacin is a highly effective empiric treatment for community-acquired lower respiratory tract infections.

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Section: Safety Considerationsmentioning

confidence: 93%

Section: Pharmacokineticsmentioning

confidence: 99%

Gemifloxacin for the Treatment of Respiratory Tract Infections: In Vitro Susceptibility, Pharmacokinetics and Pharmacodynamics, Clinical Efficacy, and Safety

Bhavnani

Andes

2005

Pharmacotherapy

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“…39,40 Bioavailability of gemifloxacin after oral administration of a single dose was not signifi-cantly impaired after a high-fat meal compared with fasting in healthy volunteers. 41 The reduction in AUC 0-∞ was 3% (95% CI -7-12%) for the 320-mg dose and 12% (95% CI 3-21%) for the 640-mg dose when taken with 240 ml of water after a meal meeting FDA requirements. No data yet describe the effect of enteral nutrition formulations on gemifloxacin bioavailability.…”

Section: Influence Of Food or Food Componentsmentioning

confidence: 94%

An Approach to Evaluating Drug-Nutrient Interactions

Santos

Boullata

2005

Pharmacotherapy

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Although the significance of interactions between drugs is widely appreciated, little attention has been given to interactions between drugs and nutrients. Pharmacists are challenged to remember documented interactions involving available drugs, and they face the possibility that each newly approved therapeutic agent may be involved not only in unrecognized drug-drug interactions but in drug-nutrient interactions as well. A more consistent approach to evaluating drug-nutrient interactions is needed. The approach must be systematic in order to assess the influence of nutritional status, food, or specific nutrients on a drug's pharmacokinetics and pharmacodynamics, as well as the influence of a drug on overall nutritional status or on the status of a specific nutrient. We provide such a process, using several recently approved drugs as working examples. Risk factors and clinical relevance are described, with distinctions made between documented and potential interactions. Application of this process by the pharmacist to any drug will help increase their expertise. Furthermore, full consideration by pharmacists of all possible interactions of the drug regimens used in practice can allow for improved patient care.

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“…Under Medication Guide of Factive ® tablets which has been approved by the U.S. Food and Drug Administration it was reported that following repeat oral doses of 320 mg of Factive ® tablets to healthy subjects (FACTIVE ® Tablets-FDA), and in another study "The effect of food on the bioavailability of oral gemifloxacin in healthy volunteers" (Allen et al, 2000a, the pharmacokinetics parameters were compare with this study in Table V. Comparison of this results with our study shows its similar to other studies.…”

Section: Stabilitymentioning

confidence: 99%

Determination of Gemifloxacin in human plasma by high performance liquid chromatography using Ultra Violet detector and its application to a bioequivalence study

Mousavi

2018

Braz. J. Pharm. Sci.

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A liquid chromatography method was developed and validated for the determination of gemifloxacin in human plasma using chloramphenicol as internal standard to achieve lower quantification limit. Acetonitrile was used to precipitated and extracted analyte and internal standard from plasma by Protein Precipitation. Analysis was performed isocratically on C 18 column using 25% acetonitrile and 75% 0.02 M phosphate buffer as mobile phase. The method was demonstrated to be linear from 0.003 µg/mL to 5 µg/mL with the lower limit of quantitation of 0.003 µg/mL. The method was successfully applied for the bioequivalence study of gemifloxacin after a single oral administration of 320 mg gemifloxacin mesylate tablets to 12 healthy volunteers.

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The effect of food on the bioavailability of oral gemifloxacin in healthy volunteers

Cited by 24 publications

References 10 publications

Gemifloxacin for the Treatment of Respiratory Tract Infections: In Vitro Susceptibility, Pharmacokinetics and Pharmacodynamics, Clinical Efficacy, and Safety

Gemifloxacin for the Treatment of Respiratory Tract Infections: In Vitro Susceptibility, Pharmacokinetics and Pharmacodynamics, Clinical Efficacy, and Safety

An Approach to Evaluating Drug-Nutrient Interactions

Determination of Gemifloxacin in human plasma by high performance liquid chromatography using Ultra Violet detector and its application to a bioequivalence study

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