Trial reportEuropean journal of clinical pharmacology2012
Pharmacokinetics and pharmacodynamics of single-dose oral tolvaptan in fasted and non-fasted states in healthy Caucasian and Japanese male subjects.
Trial report in European journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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
16 citing papers in PubMed, 30 citations in OpenAlex.
- Clinical trial on the pharmacokinetics, pharmacodynamics and safety of tolvaptan in healthy Chinese males: an open-label, single and multiple dosage, parallel group study.Frontiers in pharmacology · 2025Trial
- Low-dose tolvaptan PK/PD: comparison of patients with hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion to healthy adults.European journal of clinical pharmacology · 2017Trial
- Pharmacokinetics and Pharmacodynamics of Tolvaptan in Autosomal Dominant Polycystic Kidney Disease: Phase 2 Trials for Dose Selection in the Pivotal Phase 3 Trial.Journal of clinical pharmacology · 2017Trial
- Efficacy of tolvaptan added to furosemide in heart failure patients with advanced kidney dysfunction: a pharmacokinetic and pharmacodynamic study.Clinical pharmacokinetics · 2015Trial
- Pharmacokinetics and pharmacodynamics of oral tolvaptan in patients with varying degrees of renal function.Kidney international · 2014Trial
- Vaptans: A Narrative Review of Pharmacokinetics, Pharmacogenetics, and Clinical Applications.Cells · 2026Review
- Pharmacokinetics, pharmacodynamics and safety of 15 mg-tolvaptan administered orally for 7 consecutive days to Chinese patients with child-Pugh B cirrhosis.Frontiers in pharmacology · 2024Article
- The VJournal of endocrinological investigation · 2022Article
- Article
- Population Pharmacokinetic Analyses and Model Validation of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease.Journal of clinical pharmacology · 2019Article
- Review
- Human Sulfotransferases Enhance the Cytotoxicity of Tolvaptan.Toxicological sciences : an official journal of the Society of Toxicology · 2016Article
- Quantification of tolvaptan in rabbit plasma by LC-MS/MS: Application to a pharmacokinetic study.Journal of pharmaceutical analysis · 2015Article
- Review
- Mechanisms of tolvaptan-induced toxicity in HepG2 cells.Biochemical pharmacology · 2015Article
- Review of Tolvaptan's Pharmacokinetic and Pharmacodynamic Properties and Drug Interactions.Journal of clinical medicine · 2014Review
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo compare the pharmacokinetics and pharmacodynamics of tolvaptan in Caucasian and Japanese healthy male subjects under fasting and non-fasting conditions.
methodsThis was a single-center, parallel-group, randomized, open-label, three-period crossover trial of single oral doses of tolvaptan 30 mg under fasting and non-fasting [a high-fat, high-calorie meal (HFM) or Japanese standard meal] conditions in 25 healthy male Caucasian subjects and 24 healthy male Japanese subjects. Pharmacodynamic endpoints were urine volume and fluid balance for 0 to 24 h postdose.
resultsIn the fasted state, the plasma tolvaptan C(max) and AUC(∞) geometric mean ratios (90 % confidence interval) were 1.105 (0.845-1.444) and 1.145 (0.843-1.554) for Japanese compared to Caucasian subjects. A HFM increased the C(max) and AUC(∞) values by about 1.15-fold in both Japanese and Caucasian subjects.. Twenty-four-hour urine volumes paralleled pharmacokinetic changes, but the increases were not clinically significant. Fluid balance in the Japanese men was 1.4- to 2.0-fold more negative than that in the Caucasian men.
conclusionTolvaptan pharmacokinetics is not clinically significantly affected by race. Body weight is a factor that affects exposure. Tolvaptan can be administered with or without food.
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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.