Trial reportDrugs in R&D2025
Assessment of Pharmacokinetics and Safety with Bioequivalence of the Nitroglycerin Sublingual Tablets of Two Formulations in Chinese Healthy Subjects: A Bioequivalence Study.
Trial report in Drugs in R&D, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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.
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.
Who cites it
1 citing paper in PubMed.
- [Oral mucosal administration].Hua xi kou qiang yi xue za zhi = Huaxi kouqiang yixue zazhi = West China journal of stomatology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveNitroglycerin, a cornerstone therapy for acute angina pectoris, achieves rapid symptom relief through sublingual administration by bypassing hepatic first-pass metabolism. This study aimed to investigate the pharmacokinetics (PK), bioequivalence, and safety profiles between a test (T) formulation and a reference (R) formulation of nitroglycerin sublingual tablets in healthy volunteers (HVs).
methodsIn this single-center, randomized, open, single-dose, two-part formulations, four-cycle, two-sequence complete repeat crossover design, fasting-dose bioequivalence study, HVs (n = 36) were 1:1 divided into two groups (T-R-T-R and R-T-R-T) and received 0.6 mg of nitroglycerin sublingual with a 3 d washout. Venous blood was collected 3 h after each administration. Plasma levels of nitroglycerin were analyzed using a high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) technique, and PK parameters were calculated using noncompartmental methods.
resultsFor nitroglycerin, the bioequivalence between the test and reference formulations was assessed using the Reference-Scaled Average Bioequivalence (RSABE) method for the maximum plasma concentration (C
conclusionsThe study confirmed bioequivalence between the test and reference formulations, demonstrating equivalent absorption rates (C
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