Evidence map›Paper›PMID 36810140›Full record

Trial reportBMC pharmacology & toxicology2023

Oseltamivir phosphate for suspension is bioequivalent to TAMIFLU in healthy volunteers: a randomized, open-label clinical study.

Ying Wang, Bangzhong Tang, Jing Xie, Xiaoqin Wang, Peng Ren, Guangmei Wu, Cuixia He, Minhui Zhu, Yue Su, Jiaxiang Ding and 8 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pharmacology & toxicology, 2023. 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
0.6field-weighted citation impact, top 30% 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

0 citing papers in PubMed, 3 citations in OpenAlex.

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

18 authors at 3 institutions in 1 country.

Ying WangNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Bangzhong TangShenzhen Beimei Pharmaceutical Co, Ltd, Shenzhen, Guangdong, China.
Jing XieNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Xiaoqin WangShenzhen Beimei Pharmaceutical Co, Ltd, Shenzhen, Guangdong, China.
Peng RenShenzhen Beimei Pharmaceutical Co, Ltd, Shenzhen, Guangdong, China.
Guangmei WuShenzhen Beimei Pharmaceutical Co, Ltd, Shenzhen, Guangdong, China.
Cuixia HeNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Minhui ZhuNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Yue SuNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Jiaxiang DingNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Yuanyuan XuNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Ling FanNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Qin GeNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Yuzhou DingNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Juan ZhuNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Bingyan LiuNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Rongfang ShanNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Huan ZhouNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China. zhouhuan@bbmc.edu.cn.
First Affiliated Hospital of Bengbu Medical College · CNBengbu Medical College · CNKangmei Pharmaceutical (China) · CN

Funding

the 512 Talent Cultivation Program of Bengbu Medical College 51201313
6 · The paper itself

Abstract

purposeThe study was aimed at evaluating the bioequivalence and safety of oseltamivir phosphate for suspension, provided by Shenzhen Beimei Pharmaceutical Co. Ltd. and manufactured by Hetero Labs Limited, and the reference product TAMIFLU® in healthy Chinese subjects.

methodsA single-dose, randomized, two-phase, self-crossed model was adopted. Among 80 healthy subjects, 40 subjects in the fasting group and 40 subjects in the fed group. Subjects in the fasting group were randomized into two sequences according to the proportion of 1:1, each given 75 mg/12.5 mL of Oseltamivir Phosphate for Suspension or TAMIFLU®, and cross-administered after 7 days. Postprandial group is the same as fasting group.

resultsThe T

conclusionTwo Oseltamivir phosphate for suspensions are safe and bioequivalent.

Indexed as

FastingOseltamivirArea Under CurveCross-Over StudiesHealthy VolunteersHumansPhosphatesSuspensionsTabletsTherapeutic EquivalencyOseltamivirPhosphatesSuspensionsTabletsBioequivalenceInfluenzaOseltamivir Phosphate for suspensionPharmacokineticsSafetyTAMIFLU®

Identifiers

PMID36810140
PMCPMC9942619
OpenAlexW4321452345

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.