Evidence map›Paper›PMID 41340316›Full record

Trial reportClinical and translational science2025

Bioequivalence Study of Tadalafil Oral Soluble Film and Tadalafil Tablet in Healthy Chinese Volunteers Under Fasting Conditions.

Xin Jiang, Feifei Sun, Ping Shi, Xingli Gu, Xiaofei Zhao, Xiaoxia Zhang, Yi Xu, Xiaomeng Gao, Yaping Ma, Yao Fu and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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.

Xin JiangPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, China.ORCID 0009-0003-5598-6751
Feifei SunPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, China.ORCID 0000-0002-8161-536X
Ping ShiPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, China.
Xingli GuQilu Pharmaceutical Co., Ltd., Ji Nan, Shandong, China.
Xiaofei ZhaoQilu Pharmaceutical Co., Ltd., Ji Nan, Shandong, China.
Xiaoxia ZhangQilu Pharmaceutical Co., Ltd., Ji Nan, Shandong, China.
Yi XuPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, China.
Xiaomeng GaoPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, China.
Yaping MaPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, China.
Yao FuPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, China.
Yu CaoPhase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, China.ORCID 0000-0002-3980-8133

Funding

Qilu Pharmaceutical Co. Ltd
6 · The paper itself

Abstract

To investigate if a newly developed tadalafil oral soluble film (OSF) was bioequivalent to the approved tadalafil tablets, a clinical study was conducted in healthy Chinese male volunteers under fasting conditions. In this study, 36 volunteers were randomized into three groups and received one tadalafil tablet, one tadalafil OSF with water, or one OSF without water in each period. The dosages were all 10 mg. Blood samples were collected and centrifuged. Plasma concentrations of tadalafil were determined by liquid chromatography tandem mass spectrometry. Pharmacokinetic (PK) parameters including maximum plasma concentration (C

Indexed as

FastingPhosphodiesterase 5 InhibitorsTadalafilAdministration, OralAdultArea Under CurveEast Asian PeopleHalf-LifeHealthy VolunteersHumansMaleTabletsTherapeutic EquivalencyYoung AdultPhosphodiesterase 5 InhibitorsTabletsTadalafilbioequivalenceoral soluble filmpharmacokineticstadalafil

Identifiers

PMID41340316
PMCPMC12675823

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.