Evidence map›Paper›PMID 28695535›Full record

Trial reportClinical drug investigation2017

Single- and Multiple-Dose Pharmacokinetics, Safety and Tolerability of Lurasidone in Healthy Chinese Subjects.

Chaoying Hu, Yijun Wang, Rong Song, Chen Yu, Xiaoyan Luo, Jingying Jia

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 27% of its field
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.

NCT02174510 phase1completednot on this map

A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects

TypeinterventionalSponsorMarubeni Pharmaceuticals (Suzhou) Co., Ltd.Ran2014 to 2014Enrolled37ConditionsSchizophreniaArms20mg lurasidone, 40mg lurasidone, 80mg lurasidone, placebo
NCT02174523 phase1completednot on this map

Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects

TypeinterventionalSponsorMarubeni Pharmaceuticals (Suzhou) Co., Ltd.Ran2014 to 2014Enrolled14ConditionsSchizophreniaArms40mg lurasidone, placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
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

6 authors at 1 institution in 1 country.

Chaoying HuPhase I Clinical Research Unit, Shanghai Xuhui Central Hospital, No. 966, Huaihai Rd.(M), Shanghai, 200031, China.
Yijun WangPhase I Clinical Research Unit, Shanghai Xuhui Central Hospital, No. 966, Huaihai Rd.(M), Shanghai, 200031, China.
Rong SongPhase I Clinical Research Unit, Shanghai Xuhui Central Hospital, No. 966, Huaihai Rd.(M), Shanghai, 200031, China.
Chen YuPhase I Clinical Research Unit, Shanghai Xuhui Central Hospital, No. 966, Huaihai Rd.(M), Shanghai, 200031, China.
Xiaoyan LuoSumitomo Pharmaceuticals (Suzhou) Co. Ltd., Beijing, China.
Jingying JiaPhase I Clinical Research Unit, Shanghai Xuhui Central Hospital, No. 966, Huaihai Rd.(M), Shanghai, 200031, China. jyjia@shxh-centerlab.com.
Shanghai Xuhui Central Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe pharmacokinetics of lurasidone have been studied in healthy Japanese and Caucasian subjects, but not in Chinese subjects. The objective of this study was to evaluate the pharmacokinetics, safety, and tolerability of oral lurasidone in healthy Chinese subjects.

methodsThis single-center, randomized, parallel-group, placebo-controlled, and double-blind study evaluated the pharmacokinetics, safety, and tolerability of oral lurasidone administered as a single dose (20, 40, and 80 mg) and multiple doses for 5 days (40 mg administered once daily) in healthy Chinese subjects. Serum lurasidone and its metabolites were quantified using high-performance liquid chromatography-mass spectrometry. Pharmacokinetic parameters for lurasidone and its metabolites were calculated using non-compartmental analysis of WinNonlin

resultsSerum concentrations of lurasidone reached maximum concentration (C

conclusionLurasidone was safe and well-tolerated in healthy Chinese subjects, following single doses in the range of 20 to 80 mg and multiple doses of 40 mg/day for 5 days. Linear increase in lurasidone C

trial registrationClinicaltrials.gov identifiers NCT02174510 and NCT02174523.

Indexed as

Asian PeopleAdultArea Under CurveDose-Response Relationship, DrugDouble-Blind MethodHalf-LifeHumansLurasidone HydrochlorideMaleYoung AdultLurasidone Hydrochloride

Identifiers

PMID28695535
OpenAlexW2736067180

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.