Evidence map›Paper›PMID 30538429›Full record

Trial reportDrug design, development and therapy2018

Pharmacokinetics of single- and multiple-dose roflumilast: an open-label, three-way crossover study in healthy Chinese volunteers.

Jie Huang, Cheng-Xiao Fu, Xiao-Yan Yang, Chan Cui, Shuang Yang, Yun Kuang, Cheng-Xian Guo, Pei Hu, Qi Pei, Guo-Ping Yang

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.2field-weighted citation impact, top 45% 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.

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

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. 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

10 authors at 1 institution in 1 country.

Jie HuangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China, ygp9880@163.com.
Cheng-Xiao FuCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China, ygp9880@163.com.
Xiao-Yan YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China, ygp9880@163.com.
Chan CuiCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China, ygp9880@163.com.
Shuang YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China, ygp9880@163.com.
Yun KuangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China, ygp9880@163.com.
Cheng-Xian GuoCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China, ygp9880@163.com.
Pei HuClinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing 100032, People's Republic of China.
Qi PeiCenter for Clinical Drug Evaluation, Central South University, Changsha, Hunan 410013, People's Republic of China, ygp9880@163.com, peiqi1028@126.com.
Guo-Ping YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China, ygp9880@163.com.
Central South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo determine the pharmacokinetic properties of the common tablet of roflumilast administered in single and multiple oral doses in Chinese subjects. SUBJECTS AND

methodsBoth the single- and multiple-dose studies included 12 adults (6 males and 6 females). In this single-center, open-label study, single doses of 0.25, 0.375, and 0.5 mg were administered using a randomized, three-way crossover design, and then, the 0.375 mg dose was continued for 11 days once daily. The pharmacokinetic parameters for roflumilast and roflumilast

resultsAfter every single dose, the time to the maximum concentration (

conclusionRoflumilast was safe and well-tolerated in healthy volunteers, and a linear increase in its

Indexed as

AdolescentAdultAminopyridinesBenzamidesChinaCross-Over StudiesCyclopropanesDose-Response Relationship, DrugFemaleHealthy VolunteersHumansMaleMiddle AgedMolecular StructureTabletsYoung AdultAminopyridinesBenzamidesCyclopropanesRoflumilastTabletshealthy volunteerpharmacokineticsphosphodiesterase 4 inhibitorroflumilastroflumilast N-oxide

Identifiers

PMID30538429
PMCPMC6263297
OpenAlexW2903173077

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.