Effect of l-phenylalanine supplementation and a high-protein diet on pharmacokinetics of cefdinir in healthy volunteers: an exploratory study

Nakamura, Kōichi; Yamazaki, Akira; Ozaki, Machiko; Sahashi, Kunihiko; Shichijo, Kazuko; Nomura, Kazuo; Maeda, Masahiko; Nakamura, Tomoatsu; Fujita, Tomoe; Yokota, Shinichi; Kuroyama, Seiichi; Kumagai, Yoshito; Murakami, Masataka; Ohtani, Yoshio

doi:10.1111/j.1365-2710.2007.00826.x

Cited by 5 publications

(3 citation statements)

References 25 publications

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“…In the paper by Fujita et al (2007) it is shown that phenylalanine supplementation (2.5 g, three times a day for 12 days in healthy volunteers) did not seem to upregulate intestinal oligopeptide transport. The substance used was cefdinir, a β-lactam antibiotic with a normally low absorption (33%).…”

Section: Metabolism -Gastrointestinal Uptakementioning

confidence: 98%

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Report of the meeting on Aspartame with National Experts

2010

EFSA Supporting Publications

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DISCLAIMER The present report is published complying with the transparency principle to which the European Food Safety Authority (EFSA) is subject. The conclusions and recommendations of this report reflect those of the national experts involved in the meetings 2The conclusions and recommendations of this report reflect those of the national experts involved in the meetings on aspartame and do not necessarily represent the views of EFSA. SUMMARYThe Advisory Forum of EFSA discussed the issue of aspartame in 2007 and at the 24th AF meeting held on 6-7 December 2007 it was agreed that a special meeting would be held on aspartame. This meeting of National Experts was to take place early in 2009 and, as provided in the Terms of Reference endorsed by the Advisory Forum, was to review the information available on aspartame; agree on the completeness of the information ensuring any missing data was added; identify possible data gaps and discrepancies in the available data and where such exist to consider detailed options to address the outstanding issues.An Organising Team, nominated by members of the Advisory Forum, was tasked with preparing for the meetings of National Experts by identifying, collating and reviewing all published papers on aspartame since the review carried out by the Scientific Committee on Food in 2002. In addition the Organising Team also considered available non-peer reviewed information and anecdotal claims by individuals who attributed various symptoms and illnesses directly to aspartame consumption. A meeting was held with interested parties who had submitted information in response to a ‗call for data' published by EFSA in September, 2008.Each of the areas considered, including exposure data, brain function, satiation and appetite, allergenicity and immunotoxicity, metabolic aspects and diabetes, carcinogenicity (including cancer epidemiology) and genotoxicity were considered by the Organising Team and reported on. For each, consistent with the Terms of Reference for the National Expert Meeting, they made preliminary conclusions on whether there were data gaps or discrepancies which required further consideration. This report represents the results of these deliberations.Overall, the Organising Team did not identify any major gaps in information on aspartame and the National Experts agreed with their view. However, several suggestions are made within this report for additional data which would add to the available knowledge on aspartame and its metabolites. To address the communications element of the Terms of Reference a workshop with stakeholders and other interested parties is to be arranged to share and discuss the findings of the work.In conclusion, the National Experts have not identified any new evidence that requires a recommendation to EFSA that the previous Opinions of EFSA and the SCF need to be reconsidered. 3The conclusions and recommendations of this report reflect those of the national experts involved in the meetings on aspartame and do not necessarily represent the views of EF...

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Section: Metabolism -Gastrointestinal Uptakementioning

confidence: 98%

“…High levels of specific amino acids can also affect transporters and protein synthesis. The literature search for publications since 2002 relating to this area identified two articles that have been evaluated (Ferland et al 2007;Fujita et al 2007).…”

Section: Effects Of Aspartame On Metabolism Of Endogenous and Exogenomentioning

confidence: 99%

Report of the meeting on Aspartame with National Experts

2010

EFSA Supporting Publications

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“…Chen et al [ 6 ] introduced a sensitive LC-MS/MS method for cefdinir determination in human plasma, which needed high requirement of instruments and bear high-cost. Fujita et al [ 7 ] reported a modifi ed HPLC method for pharmacokinetic study using solid-phase A simple and sensitive HPLC method was developed to determine cefdinir (CAS 91832-40-5) in human plasma. The method was validated by investigating the accuracy and precision for intraand inter-day runs in a linear concentration from 0.05-2.0 μg/ml.…”

Section: Introduction ▼mentioning

confidence: 99%

Bioequivalence Evaluation of Cefdinir in Healthy Fasting Subjects

Chen

Lou

et al. 2012

Arzneimittelforschung

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A simple and sensitive HPLC method was developed to determine cefdinir (CAS 91832-40-5) in human plasma. The method was validated by investigating the accuracy and precision for intra- and inter-day runs in a linear concentration from 0.05-2.0 µg/ml. The object of this study was to compare the bioavailability of cefdinir capsule (reference) and cefdinir granule (test) containing 100 mg of cefdinir. A randomized, open-label, single-dose, 2-way crossover bioequivalence study in 20 healthy, Chinese, male subjects was conducted. A 1-week wash-out period was applied. Blood samples were collected before and with 10 h after drug administration. The formulations were compared using the following pharmacokinetic parameters: AUC0-t, AUC0-∞ and C max. The 90% confidence interval (CI) of the ratios of log-transformed AUC0-t and AUC0-∞ were used to assess bioequivalence between the 2 formulations using the equivalence interval of 80 and 125%. The results showed that the 90% CI of the ratios of AUC0-t, AUC0-∞ and C max were 102.5% (94.7-111.0%), 103.4% (94.8-112.7%) and 106.4% (97.0-116.7%), respectively, which indicated 2 formulations of cefidinir are bioequivalent. Both treatments showed similar tolerability and safety.

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