Trial reportAndrology2026
Pharmacokinetics, pharmacodynamics, and safety interaction study of tunodafil hydrochloride and alcohol: A randomized, blinded, placebo-controlled, three-cycle crossover study in Chinese healthy men.
Trial report in Andrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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.
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
2 citing papers in PubMed.
- Trial
- Ethanol as a Modifier of Drug Toxicity in Humans: Pathways of Toxicity and Organ-Level Consequences.International journal of molecular sciences · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
objectivesThis study aimed to evaluate the pharmacodynamic effects of administering tunodafil hydrochloride with alcohol on blood pressure and heart rate in healthy Chinese males, and to investigate the mutual pharmacokinetic interactions and safety of the combination.
methodsThe trial was a randomized, blinded, placebo-controlled, three-cycle crossover design, with one administration in each cycle and a 7-day washout interval between cycles. Eighteen healthy men were randomized to receive tunodafil hydrochloride with an alcoholic beverage, placebo with an alcoholic beverage, or tunodafil hydrochloride with a placebo beverage in each cycle. The primary endpoints included plasma concentrations of tunodafil, metabolite M459, and alcohol, as well as supine blood pressure and heart rate measurements. The secondary endpoint was the incidence of adverse events.
resultsPharmacokinetic results demonstrated that the combined drug and alcohol group did not affect plasma alcohol concentration compared to alcohol alone. However, co-administration led to increased systemic exposure of tunodafil and its metabolite M459: AUC
conclusionThe study concluded that tunodafil hydrochloride, when taken with alcohol, does not interfere with alcohol metabolism but moderately enhances the tunodafil and metabolite exposure. Alcohol remained the dominant factor in lowering blood pressure, while tunodafil contributed to an additive increase in heart rate. The combination does not significantly increase adverse events.
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Registered trials
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.