Evidence map›Paper›PMID 27747530›Full record

ArticleRheumatology and therapy2015

Pharmacokinetics and Bioequivalence Study of Hydroxychloroquine Sulfate Tablets in Chinese Healthy Volunteers by LC-MS/MS.

Hong-Wei Fan, Zhi-Xiang Ma, Jing Chen, Xing-Ye Yang, Jun-Lin Cheng, Ying-Bin Li

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology and therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
0.9field-weighted citation impact, top 26% 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

18 citing papers in PubMed, 39 citations in OpenAlex.

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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.

Hong-Wei FanDepartment of Clinical Pharmacology Laboratory, Nanjing First Hospital, Nanjing Medical University, 210006, Nanjing, Jiang Su, China. fanhongwei178@sina.com.
Zhi-Xiang MaDepartment of Clinical Pharmacology Laboratory, Nanjing First Hospital, Nanjing Medical University, 210006, Nanjing, Jiang Su, China.
Jing ChenXenoBiotic Laboratories China, 210038, Nanjing, China.
Xing-Ye YangXenoBiotic Laboratories China, 210038, Nanjing, China.
Jun-Lin ChengDepartment of Clinical Pharmacology Laboratory, Nanjing First Hospital, Nanjing Medical University, 210006, Nanjing, Jiang Su, China.
Ying-Bin LiThe 2nd Affliated Hospital of Nanjing Medical University, 210011, Nanjing, China. Yingbinli65@sina.com.
Nanjing Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHydroxychloroquine (HCQ), 4-aminoquinoline, is an antimalarial drug and has become a basic therapy for rheumatic disease treatment. It can stabilize the condition of SLE patients and reduce the chances of patient relapse through its immunosuppressive function and antiinflammatory effects. This drug was absorbed completely and rapidly by oral administration, but has a prolonged half-life for elimination. The objective of this study was to evaluate the pharmacokinetic parameters and relative bioequivalence of a new generic (test) formulation with the branded (reference) formulation of HCQ in healthy Chinese male volunteers. This study was designed to acquire regulatory approval for the test formulation.

methodsThis study was conducted with a randomized, single-dose, two-period, and crossover design. The male subjects were randomly assigned to two groups at a 1:1 ratio to receive 0.2 g hydroxychloroquine sulfate tablets (0.1 g/piece) of the two formulations after a 3-month washout period then administered the alternate formulation. Study drugs were administered after overnight fasting (over 10 h). Plasma concentrations of hydroxychloroquine were measured by a validated LC-MS/MS method. The following pharmacokinetic properties were determined by a noncompartmental pharmacokinetic method: C

resultsThe 90% CI of C

conclusionsIn this study, the pharmacokinetic studies and results were conducted so that the test and reference formulations of HCQ met the Chinese criteria for assuming bioequivalence. Both formulations were well tolerated in the population studies.

Indexed as

BioequivalenceHydroxychloroquine (HCQ)Pharmacokinetics

Identifiers

PMID27747530
PMCPMC4883261
OpenAlexW996465921

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.