Abstract
Background and Objectives
No pharmacokinetic data of intravenous ibuprofen were available in a Chinese population and the published information remained inadequate. The present study aimed to investigate the pharmacokinetic properties of intravenous ibuprofen in healthy Chinese volunteers after single- and multiple-dose administration.
Methods
Twelve subjects received single doses of 200, 400, and 800 mg intravenous ibuprofen, respectively, and multiple doses of 400 mg intravenous ibuprofen, four times per day (every 6 h) till the morning of the sixth day in each study period.
Results
After single doses of 200, 400 and 800 mg and multiple doses of 400 mg intravenous ibuprofen, the main pharmacokinetic parameters obtained were: maximum plasma concentration (C max) 23.05 ± 2.96, 41.90 ± 3.22, 76.06 ± 8.70, and 49.53 ± 3.92 μg/ml, respectively, which were achieved immediately at the end of the infusion; area under the plasma concentration–time curve from time zero to the time of last quantifiable concentration (AUC0–t ) 49.82 ± 10.92, 88.79 ± 12.43, 152.34 ± 25.23, and 106.68 ± 18.94 µg·h/mL, respectively; AUC from time zero to infinity (AUC0−∞) 51.91 ± 10.67, 91.46 ± 12.06, 155.04 ± 25.70, and 108.58 ± 19.49 µg·h/ml, respectively; half-life (t ½) 1.87 ± 0.30, 1.93 ± 0.24, 2.02 ± 0.38, and 1.74 ± 0.26 h, respectively. The accumulation index (AI) was 1.22 ± 0.17 after multiple doses. The most obvious accumulation was observed in males; other parameters revealed no significant differences.
Conclusions
Similar pharmacokinetic properties of intravenous ibuprofen in healthy Chinese volunteers were observed to those reported in a Caucasian population. Multiple doses of intravenous ibuprofen every 6 h caused slight accumulation. Except for the AI, sex did not affect the pharmacokinetics of intravenous ibuprofen.
Chictr.org identifier
ChiCTR-IIR-15007347.
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Funding
The study was sponsored and funded by Beijing Alica Pharmaceutical Sci-Tech Co. Ltd. (Beijing, People’s Republic of China).
Conflict of interest
Yali Shen, Feng Nan, Mei Li, Maozhi Liang, Ying Wang, Zhihui Chen, and Zhu Luo declare that they have no financial relationships with any organizations that might have an interest in the submitted work, nor any other relationships or activities that could influence the submitted work.
Ethical approval
The study protocol was approved by the Independent Ethics Committee of West China Hospital, Sichuan University (Chengdu, China). Written informed consent was obtained from each subject before screening procedures. All procedures in this study were carried out in accordance with the Helsinki declaration.
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Shen, Y., Nan, F., Li, M. et al. Pharmacokinetic Properties of Intravenous Ibuprofen in Healthy Chinese Volunteers. Clin Drug Investig 36, 1051–1058 (2016). https://doi.org/10.1007/s40261-016-0453-4
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DOI: https://doi.org/10.1007/s40261-016-0453-4