Pharmacokinetics, safety, and tolerability of a rapid infusion of i.v. ibuprofen in healthy adults
| Autor: | Leo Pavliv, Bryan Voss, Amy Dix Rock |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Administration Oral Ibuprofen Placebo Gas Chromatography-Mass Spectrometry Double-Blind Method Pharmacokinetics Humans Medicine Infusions Intravenous Adverse effect Pharmacology Cross-Over Studies business.industry organic chemicals Health Policy Anti-Inflammatory Agents Non-Steroidal Crossover study Bioavailability Tolerability Concomitant Anesthesia Female business Half-Life medicine.drug |
| Zdroj: | American Journal of Health-System Pharmacy. 68:47-51 |
| ISSN: | 1535-2900 1079-2082 |
| Popis: | Purpose The pharmacokinetics, safety, and tolerability of a rapid infusion of i.v. ibuprofen in healthy adults were evaluated. Methods In this randomized, double-blind, placebo-controlled, single-dose, crossover study, 12 healthy subjects age 18–65 years were randomized to receive a single dose of either 800 mg i.v. ibuprofen (infused over five to seven minutes) concomitantly with an oral placebo or 800 mg oral ibuprofen with concomitant i.v. placebo (0.9% sodium chloride injection). After a six-day washout period, subjects received the treatment not previously received. Blood samples were taken 1 hour before each dose of study medication was administered and throughout the 12 hours thereafter. Plasma ibuprofen concentrations were determined using validated liquid chromatography–tandem mass spectrometry methods. The frequency and severity of treatment-emergent adverse effects were monitored throughout the study. Results The maximum plasma concentration ( C max) of i.v. ibuprofen was approximately twice that of oral ibuprofen, and the ( t max) of i.v. ibuprofen was 0.11 hour, compared with 1.5 hours for oral ibuprofen. However, the elimination half-life of i.v. and oral ibuprofen did not differ, both of which were approximately 2 hours. Oral ibuprofen was 100% bioavailable; therefore, the area under the concentration–time curve did not differ between i.v. and oral ibuprofen. In addition, i.v. ibuprofen infused over five to seven minutes did not differ in terms of safety or tolerability when compared with oral ibuprofen. Conclusion I.V. ibuprofen, when administered over five to seven minutes in healthy subjects, achieved a higher C max and a more-rapid t max than did oral ibuprofen and was found to be safe and well tolerated. |
| Databáze: | OpenAIRE |
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