Evidence map›Paper›PMID 27180987›Full record

Trial reportActa pharmacologica Sinica2016

Population pharmacokinetic modeling and simulation of huperzine A in elderly Chinese subjects.

Lei Sheng, Yi Qu, Jing Yan, Gang-Yi Liu, Wei-Liang Wang, Yi-Jun Wang, Hong-Yi Wang, Meng-Qi Zhang, Chuan Lu, Yun Liu and 5 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Acta pharmacologica Sinica, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Lei ShengDepartment of Clinical Pharmacology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Yi QuDepartment of Geriatrics, Central Hospital of Shanghai Xuhui, Shanghai 200031, China.
Jing YanZhejiang Hospital, Hangzhou 310013, China.
Gang-Yi LiuCentral Laboratory, Central Hospital of Shanghai Xuhui, Shanghai 200031, China.
Wei-Liang WangDepartment of Geriatrics, Central Hospital of Shanghai Xuhui, Shanghai 200031, China.
Yi-Jun WangCentral Laboratory, Central Hospital of Shanghai Xuhui, Shanghai 200031, China.
Hong-Yi WangCentral Laboratory, Central Hospital of Shanghai Xuhui, Shanghai 200031, China.
Meng-Qi ZhangCentral Laboratory, Central Hospital of Shanghai Xuhui, Shanghai 200031, China.
Chuan LuCentral Laboratory, Central Hospital of Shanghai Xuhui, Shanghai 200031, China.
Yun LiuCentral Laboratory, Central Hospital of Shanghai Xuhui, Shanghai 200031, China.
Jing-Yin JiaCentral Laboratory, Central Hospital of Shanghai Xuhui, Shanghai 200031, China.
Chao-Ying HuCentral Laboratory, Central Hospital of Shanghai Xuhui, Shanghai 200031, China.
Xue-Ning LiDepartment of Clinical Pharmacology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Chen YuCentral Laboratory, Central Hospital of Shanghai Xuhui, Shanghai 200031, China.
Hong-Rong XuDepartment of Clinical Pharmacology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimOur preliminary results show that huperzine A, an acetylcholinesterase inhibitor used to treat Alzheimer's disease (AD) patients in China, exhibits different pharmacokinetic features in elderly and young healthy subjects. However, its pharmacokinetic data in elderly subjects remains unavailable to date. Thus, we developed a population pharmacokinetic (PPK) model of huperzine A in elderly Chinese people, and identified the covariate affecting its pharmacokinetics for optimal individual administration.

methodsA total of 341 serum huperzine A concentration records was obtained from 2 completed clinical trials (14 elderly healthy subjects in a phase I pharmacokinetic study; 35 elderly AD patients in a phase II study). Population pharmacokinetic analysis was performed using the non-linear mixed-effect modeling software Phoenix NLME1.1.1. The effects of age, gender, body weight, height, creatinine, endogenous creatinine clearance rate as well as drugs administered concomitantly were analyzed. Bootstrap and visual predictive checks were used simultaneously to validate the final population pharmacokinetics models.

resultsThe plasma concentration-time profile of huperzine A was best described by a one-compartment model with first-order absorption and elimination. Age was identified as the covariate having significant influence on huperzine A clearance. The final PPK model of huperzine A was: CL (L/h)=2.4649(*)(age/86)((-3.3856)), Ka=0.6750 h(-1), V (L)=104.216. The final PPK model was demonstrated to be suitable and effective by the bootstrap and visual predictive checks.

conclusionA PPK model of huperzine A in elderly Chinese subjects is established, which can be used to predict PPK parameters of huperzine A in the treatment of elderly AD patients.

Indexed as

Models, BiologicalAgedAged, 80 and overAgingAlkaloidsAsian PeopleBody HeightBody WeightCreatinineFemaleHumansMaleMiddle AgedNonlinear DynamicsSesquiterpenesSex CharacteristicsAlkaloidsCreatininehuperzine ASesquiterpenes

Identifiers

PMID27180987
PMCPMC4933756

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.