Pharmacokinetics and safety of MP-376 (levofloxacin inhalation solution) in cystic fibrosis subjects
| Autor: | David E. Geller, Dan White, Jeffery Loutit, Elizabeth E. Morgan, Michael N. Dudley, David C. Griffith, Patrick A. Flume |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Ofloxacin Adolescent Cystic Fibrosis Cmax Levofloxacin Pharmacology Pharmacokinetics Administration Inhalation Medicine Humans Pharmacology (medical) Single-Blind Method Cross-Over Studies Inhalation business.industry Liter Middle Aged Crossover study Anti-Bacterial Agents Solutions Infectious Diseases Tolerability Area Under Curve Female business medicine.drug |
| Zdroj: | Antimicrobial agents and chemotherapy. 55(6) |
| ISSN: | 1098-6596 |
| Popis: | The pharmacokinetics and tolerability of nebulized MP-376 (levofloxacin inhalation solution [Aeroquin]) were determined in cystic fibrosis (CF) subjects. Ten CF subjects received single 180-mg doses of two formulations of MP-376, followed by a multiple-dose phase of 240 mg once daily for 7 days. Serum and expectorated-sputum samples were assayed for levofloxacin content. Safety was evaluated following the single- and multiple-dose study phases. Nebulized MP-376 produced high concentrations of levofloxacin in sputum. The mean maximum plasma concentration ( C max ) ranged between 2,563 and 2,932 mg/liter for 180-mg doses of the 50- and 100-mg/ml formulations, respectively. After 7 days of dosing, the mean C max for the 240-mg dose was 4,691 mg/liter. The mean serum levofloxacin C max ranged between 0.95 and 1.28 for the 180-mg doses and was 1.71 for the 240-mg dose. MP-376 was well tolerated. Nebulized MP-376 produces high sputum and low serum levofloxacin concentrations. The pharmacokinetics, safety, and tolerability were similar for the two formulations. MP-376 240 mg (100 mg/ml) is being advanced into late-stage clinical development. |
| Databáze: | OpenAIRE |
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