Evidence map›Paper›PMID 40949117›Full record

ArticleFrontiers in pharmacology2025

Pharmacokinetics and safety of highly variable nitroglycerin lingual spray (NLS) versus US-licensed nitroglycerin lingual spray reference product (Nitrolingual

Yingying Fang, Lu Qi, Yu Wang, Chunyu Han, Qian Zhang, Xiaoyun Liu, Ju Liu, Xiaoqiang Cheng, Yinjuan Li, Yan Li and 6 more

Abstract read
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In one paragraph

Article in Frontiers in pharmacology, 2025. 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

16 authors.

Yingying Fang *Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Lu Qi *Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yu WangDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Chunyu HanDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Qian ZhangDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Xiaoyun LiuDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Ju LiuDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Xiaoqiang ChengDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yinjuan LiDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yan LiDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Mingli SunDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Long LiuDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Pu LiDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yingjuan ZhangDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Huijuan LiuDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Xinghe WangDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: In this Phase I study, we aimed to evaluate the pharmacokinetic bioequivalence and the safety of a nitroglycerin lingual spray (NLS) compared with US-approved Nitrolingual in healthy subjects. Methods: Subjects (N = 56) were randomized 1:1 to receive one 96-mg NLS, US-approved Nitrolingual; safety was assessed for 11 days. Bioequivalence was evaluated using the average bioequivalence method to test whether the 90% confidence intervals (CIs) of the geometric means (NLS vs. US-approved Nitrolingual) for the primary endpoints were within prespecified acceptable ranges (80%-125%). Results: After the single administration of NLS (test preparation vs. reference preparation) under fasting conditions, the geometric mean ratios (GMRs) of C Conclusion: The bioequivalence of NLS to US-approved Nitrolingual was demonstrated; the safety results of the two study drugs were also similar. These studies provided robust evidence of the pharmacokinetics similarity between NLS and US-approved originator Nitrolingual. Clinical Trial Registration: http://www.chinadrugtrials.org.cn/index.html, identifier CTR20230675.

Indexed as

bioequivalenceearly clinical trialnitroglycerin lingual spraypharmacokineticssafety

Identifiers

PMID40949117
PMCPMC12422889

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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.