Trial reportActa pharmacologica Sinica2009
Effect of bifendate on the pharmacokinetics of cyclosporine in relation to the CYP3A4*18B genotype in healthy subjects.
Trial report in Acta pharmacologica Sinica, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed, 22 citations in OpenAlex.
- Association of CYP3A polymorphisms with the pharmacokinetics of cyclosporine A in early post-renal transplant recipients in China.Acta pharmacologica Sinica · 2012Trial
- Antioxidant activity and hepatoprotective effect of 10 medicinal herbs on CClWorld journal of gastroenterology · 2020Article
- Pharmacokinetic and Pharmacogenetic Factors Contributing to Platelet Function Recovery After Single Dose of Ticagrelor in Healthy Subjects.Frontiers in pharmacology · 2019Article
- Effect ofFrontiers in pharmacology · 2017Article
- Clinical implementation of pharmacogenetics in kidney transplantation: calcineurin inhibitors in the starting blocks.British journal of clinical pharmacology · 2014Review
- Pharmacogenetics in kidney transplantation: recent updates and potential clinical applications.Molecular diagnosis & therapy · 2012Review
- Effect of CYP3A and ABCB1 single nucleotide polymorphisms on the pharmacokinetics and pharmacodynamics of calcineurin inhibitors: Part I.Clinical pharmacokinetics · 2010Review
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo evaluate the potential drug-drug interactions between bifendate and cyclosporine, a substrate of CYP3A4, in relation to different CYP3A4*18B genotype groups.
methodsEighteen unrelated healthy subjects (six CYP3A4*1*1, six CYP3A4*1/*18B, and six CYP3A4*18/*18B) were selected for this study. After repeated oral administration of a placebo or bifendate (three times daily for 14 d), the whole-blood level of cyclosporine was measured using high performance liquid chromatography-electrospray mass spectrometry (HPLC/ESI-MS). This study was carried out in a two-phase randomized crossover manner.
resultsAfter the treatment with bifendate, the areas under the curve (AUC(0-24) and AUC(0-infinity)) decreased significantly by 9.7%+/-3.7% (P=0.01) and 19.2%+/-16.8% (P=0.001) in CYP3A4*1/*1 subjects, 11.3%+/-9.4% (P=0.03) and 10.5%+/-9.6% (P=0.043) in CYP3A4*1/*18B subjects, and 40.2%+/-14.7% (P=0.02) and 37.5%+/-15.8% (P=0.003) in CYP3A4*18B/*18B subjects. Meanwhile, the decreases in the AUC(0-24) and AUC(0-infinity) values in the three groups were significantly different (using one-way analysis of variance, P=0.001 and P=0.001), and the change in the CYP3A4*18B/*18B group was greater than that in the other two groups. The oral clearance of cyclosporine was altered in all the subjects, with substantial increases by 10.2%+/-4.4% (P=0.004) in CYP3A4*1/*1 subjects, 14.0%+/-12.0% (P=0.048) in CYP3A4*1/*18B subjects, and 32.4%+/-21.7% (P=0.013) in CYP3A4*18B/*18B subjects.
conclusionThese results suggest that bifendate decreases the plasma concentration of cyclosporine in a CYP3A4 genotype-dependent manner.
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