دورية أكاديمية
Pharmacokinetics of Sublingual Buprenorphine Tablets Following Single and Multiple Doses in Chinese Participants With and Without Opioid Use Disorder
| العنوان: | Pharmacokinetics of Sublingual Buprenorphine Tablets Following Single and Multiple Doses in Chinese Participants With and Without Opioid Use Disorder |
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| المؤلفون: | Ruihua Dong, Hongyun Wang, Dandan Li, Liwei Lang, Frank Gray, Yongzhen Liu, Celine M. Laffont, Malcolm Young, Ji Jiang, Zeyuan Liu, Susan M. Learned |
| المصدر: | Drugs in R&D, Vol 19, Iss 3, Pp 255-265 (2019) |
| بيانات النشر: | Adis, Springer Healthcare, 2019. |
| سنة النشر: | 2019 |
| المجموعة: | LCC:Therapeutics. Pharmacology |
| مصطلحات موضوعية: | Therapeutics. Pharmacology, RM1-950 |
| الوصف: | Abstract Background Two phase I studies assessed the pharmacokinetics of buprenorphine, its metabolite norbuprenorphine, and naloxone following administration of buprenorphine/naloxone sublingual tablets in Chinese participants. Methods In the first phase I, open-label, single ascending-dose (SAD) study, 82 opioid-naïve volunteers received a single buprenorphine/naloxone dose ranging from 2 mg/0.5 mg to 24 mg/6 mg while under naltrexone block. In a second phase I, open-label, multiple ascending-dose (MAD) study, 27 patients with opioid dependence in withdrawal received buprenorphine/naloxone doses of either 16 mg/4 mg or 24 mg/6 mg for 9 consecutive days. Serial blood samples were collected after a single dose (SAD study) and at steady-state (MAD study). Pharmacokinetic parameters were calculated using non-compartmental analysis. Safety assessments included adverse events monitoring and laboratory tests. Results The pharmacokinetic profiles of buprenorphine and naloxone were consistent between single- and multiple-dose studies. Peak plasma concentrations (C max) were reached early for buprenorphine (0.75–1.0 h) and naloxone (0.5 h), supporting rapid absorption. In the SAD study, increases in plasma exposures to buprenorphine and naloxone were less than dose proportional, in line with previous observations in Western populations. Buprenorphine-to-naloxone ratios for C max and area under the curve (AUC) were constant over the dose range investigated and also consistent with Western populations data. Steady state was reached within 7 days of daily dosing, with slight accumulation over repeated doses. No serious adverse events were observed. Conclusions The present data suggest that buprenorphine/naloxone pharmacokinetic profiles in Chinese participants are consistent, overall, with those in Western populations, supporting no differences in dosing. Clinical Trial Registration The protocols were registered on the official website of the China Food and Drug Administration (CFDA): http://www.chinadrugtrials.org.cn/ ; Registration numbers CTR20132963 (RB-CN-10-0012), CTR20140153 (RB-CN-10-0015). |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 1174-5886 1179-6901 |
| Relation: | http://link.springer.com/article/10.1007/s40268-019-0277-9; https://doaj.org/toc/1174-5886; https://doaj.org/toc/1179-6901 |
| DOI: | 10.1007/s40268-019-0277-9 |
| URL الوصول: | https://doaj.org/article/79bde2a917974800ab91d5b4112163f5 |
| رقم الأكسشن: | edsdoj.79bde2a917974800ab91d5b4112163f5 |
| قاعدة البيانات: | Directory of Open Access Journals |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 11745886 11796901 |
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| DOI: | 10.1007/s40268-019-0277-9 |