Trial reportFrontiers in pharmacology2025
Clinical trial on the pharmacokinetics, pharmacodynamics and safety of tolvaptan in healthy Chinese males: an open-label, single and multiple dosage, parallel group study.
Trial report in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.
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.
Pharmacokinetics, Pharmacological Effects and Safety of Single Dose of 7.5mg Tolvaptan Tablet in Healthy Male Subjects
Tolvaptan Oral Administration Phase I Clinical Trial
Pharmacokinetics, Pharmacological Effects and Safety of Multi Dose of 7.5mg Tolvaptan Tablet in Healthy Male Subjects
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: To determine the pharmacokinetics (PK), pharmacodynamics (PD) and safety of tolvaptan in healthy Chinese males. Methods: Three separate clinical trials were carried out on healthy Chinese males aged 18-45 years. Fifty received a single dose of tolvaptan of 7.5, 15, 30, 60 and 120 mg. In addition, 36 received multiple doses of 7.5, 30 and 60 mg once a day for 7 days. The primary outcomes measured were the PK parameters of tolvaptan and its two metabolites (DM-4103, DM-4107). Secondary endpoints included serum electrolytes, urine volume and water intake, which were monitored as pharmacological indicators. The safety profile was also evaluated in detail. Results: After the administration of a single dose of tolvaptan, dose proportionality was observed for the area under the concentration-time curve (AUC) from 7.5 mg to 120 mg, but not for the maximum plasma concentration (C Conclusion: Tolvaptan demonstrated good tolerability and efficacy after single doses up to 120 mg and multiple doses up to 60 mg per day for 7 days. Dose proportionality was observed for AUC from 7.5 mg to 120 mg, but not for C Clinical Trial Registration: https://clinicaltrials.gov/, identifier NCT07166796, NCT07166783 and NCT07166887.
Indexed as
Identifiers
What Socratic holds
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 Socratic graph.