Evidence map›Paper›PMID 41851591›Full record

Trial reportDrugs in R&D2026

Pharmacokinetics and Bioequivalence Evaluation of Piracetam Tablet: A Randomized, Single-Dose, Two-Period, Crossover Study in Healthy Chinese Participants Under Fasting and Fed Conditions.

Hegui Yan, Ming Zhou, Zhixiang Pan, Yu Peng, Jie Wang, Xiuwen Li, Yafang Xie, Qianying Liu, Cuiping Huang, Qiuhong Wang and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drugs in R&D, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Hegui YanPhase I Clinical Research Center, Wuhan Pulmonary Hospital, Wuhan Institute of Tuberculosis Prevention and Control, Wuhan, China.
Ming ZhouPhase I Clinical Research Center, Wuhan Pulmonary Hospital, Wuhan Institute of Tuberculosis Prevention and Control, Wuhan, China.
Zhixiang PanPhase I Clinical Research Center, Wuhan Pulmonary Hospital, Wuhan Institute of Tuberculosis Prevention and Control, Wuhan, China.
Yu PengPhase I Clinical Research Center, Wuhan Pulmonary Hospital, Wuhan Institute of Tuberculosis Prevention and Control, Wuhan, China.
Jie WangPhase I Clinical Research Center, Wuhan Pulmonary Hospital, Wuhan Institute of Tuberculosis Prevention and Control, Wuhan, China.
Xiuwen LiPhase I Clinical Research Center, Wuhan Pulmonary Hospital, Wuhan Institute of Tuberculosis Prevention and Control, Wuhan, China.
Yafang XiePhase I Clinical Research Center, Wuhan Pulmonary Hospital, Wuhan Institute of Tuberculosis Prevention and Control, Wuhan, China.
Qianying LiuClinical Research Department, China Resources Double-Crane Limin Pharmaceutical Co., Ltd. (Jinan, China), Jinan, China.
Cuiping HuangClinical Research Department, China Resources Double-Crane Limin Pharmaceutical Co., Ltd. (Jinan, China), Jinan, China.
Qiuhong WangClinical Research Department, China Resources Double-Crane Limin Pharmaceutical Co., Ltd. (Jinan, China), Jinan, China.
Guan LiuPhase I Clinical Research Center, Wuhan Pulmonary Hospital, Wuhan Institute of Tuberculosis Prevention and Control, Wuhan, China. liuguantbdoctor@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPiracetam, a nootropic drug, is widely used for treating cognitive impairments. However, pharmacokinetic and bioequivalence data for piracetam formulations in the Chinese population are limited. This study was conducted to evaluate the pharmacokinetics and bioequivalence of a newly developed generic piracetam tablet compared with the reference product (Nootropyl

methodsA randomized, open-label, single-dose, two-period, two-sequence crossover study was conducted in healthy Chinese participants under fasting and fed conditions. Healthy participants received a single oral dose of piracetam 800 mg as either the test or reference formulation, followed by a 7-day washout period. Plasma piracetam concentrations were determined using a validated high-performance liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters, including maximum plasma concentration (C

results56 participants were enrolled, with 28 participants completing each study under fasting and fed conditions. Under fasting conditions, the 90% confidence intervals (CIs) of the GMRs for C

conclusionsThe test piracetam tablet was demonstrated to be bioequivalent to the reference formulation with respect to the rate and extent of absorption under both fasting and fed conditions in healthy Chinese participants. The comparable safety and tolerability profiles support the clinical interchangeability of the generic and reference piracetam formulations. CLINICAL

trial registrationCTR20213027.

Indexed as

Nootropic AgentsPiracetamAdministration, OralAdultArea Under CurveChromatography, High Pressure LiquidCross-Over StudiesDrugs, GenericEast Asian PeopleFastingFemaleHealthy VolunteersHumansMaleTabletsTandem Mass SpectrometryDrugs, GenericNootropic AgentsPiracetamTablets

Identifiers

PMID41851591
PMCPMC13076839

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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.