Trial reportScientific reports2025
Pharmacokinetic and bioequivalence of two formulations of Valsartan/Amlodipine Tablet(I) in healthy Chinese volunteers: A randomized, three-period, partially replicated crossover study.
Trial report in Scientific reports, 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
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
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Valsartan/amlodipine combination tablets can exert synergistic antihypertensive effects through different mechanisms, significantly lowering blood pressure while also addressing multiple risk factors and comorbidities in patients. This study designed a single-center, randomized, open-label, two-formulations, single-dose, three-cycle, three-sequence, partially repeated crossover controlled trial design. A total of 72 healthy Chinese volunteers participated in the fasting and fed trials, of whom 69 completed the trial process. This study employed a methodologically validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to determine the concentrations of valsartan and amlodipine in plasma. Phoenix WinNonlin software (version 7.0) was used to calculate pharmacokinetic parameters using a non-compartmental model. Equivalence analysis was performed using the average bioequivalence (ABE) method and the reference-scaled average bioequivalence (RSABE) method. The trial results showed that the test drug was bioequivalent to the reference drug, and no suspected serious adverse reactions or serious adverse events occurred throughout the trial. The results of this study support the launch of the new generic Valsartan/Amlodipine Tablet(I) in China. As a representative antihypertensive fixed-dose combination (FDC), these methodological insights can be directly applied to clinical trials of similar drug products, thereby enhancing success rates while mitigating development risks.Clinical trial registration: CTR20221889, ( http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml.28/07/2022 ).
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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.