Article date: July 2010
By: Hyunmi Kim, Soo Kyung Bae, Soo‐Jin Park, Eon‐Jeong Shim, Ho‐Sook Kim, Ji‐Hong Shon, Kwang‐Hyeon Liu, Jae‐Gook Shin, in Volume 70, Issue 1, pages 126-131
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
AIMS
To examine the effects of woohwangcheongsimwon suspension on the pharmacokinetics of bupropion and its active metabolite, 4‐hydroxybupropion, formed via CYP2B6 in vivo.
METHODS
A two‐way crossover clinical trial with a 2 week washout period was conducted in 14 healthy volunteers. In phases I and II, subjects received 150 mg bupropion with or without woohwangcheongsimwon suspension four times (at −0.17, 3.5, 23.5 and 47.5 h, with the time of bupropion administration taken as 0 h) in a randomized balanced crossover order. Bupropion and 4‐hydroxybupropion plasma concentrations were measured for up to 72 h by LC‐MS/MS. Urine was collected up to 24 h to calculate the renal clearance. In addition, the CYP2B6*6 genotype was also analyzed.
RESULTS
The geometric mean ratios and 90% confidence interval of bupropion with woohwangcheongsimwon suspension relative to bupropion alone were 0.976 (0.917, 1.04) for AUC(0,∞) and 0.948 (0.830,1.08) for Cmax, respectively. The corresponding values for 4‐hydroxybupropion were 0.856 (0.802, 0.912) and 0.845 (0.782, 0.914), respectively. The tmax values of bupropion and 4‐hydroxybupropion were not significantly different between the two groups (P > 0.05). The pharmacokinetic parameters of bupropion and 4‐hydroxybupropion were unaffected by woohwangcheongsimwon suspension.
CONCLUSIONS
These results indicate that woohwangcheongsimwon suspension has a negligible effect on the disposition of a single dose of bupropion in vivo. As a result, temporary co‐administration with woohwangcheongsimwon suspension does not seem to require a dosage adjustment of bupropion.
DOI: 10.1111/j.1365-2125.2010.03661.x
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