Evidence map›Paper›PMID 39781445›Full record

Trial reportDrug design, development and therapy2025

Pharmacokinetics and Bioequivalence of Two Fixed-Dose Combination Tablets of Valsartan/Amlodipine (80/5 Mg) in Healthy Chinese Subjects.

Mengli Tian, Jinlong Huang, Yingrong Chen, Qiuyue Jin, Hong Jiang, Cunyuan Shi, Jue Mei, Min Xu, Xiang Yu, Shuixin Yang

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Mengli TianClinical Trial Center, Huzhou Central Hospital, Fifth School of Clinical Medicine of Zhejiang Chinese Medical University, Huzhou, 313000, People's Republic of China.
Jinlong HuangZhejiang Jianfeng Pharmaceutical Co Ltd., Jinhua, 321025, People's Republic of China.
Yingrong ChenClinical Trial Center, Huzhou Central Hospital, Fifth School of Clinical Medicine of Zhejiang Chinese Medical University, Huzhou, 313000, People's Republic of China.
Qiuyue JinClinical Trial Center, Huzhou Central Hospital, Fifth School of Clinical Medicine of Zhejiang Chinese Medical University, Huzhou, 313000, People's Republic of China.
Hong JiangZhejiang Jianfeng Pharmaceutical Co Ltd., Jinhua, 321025, People's Republic of China.
Cunyuan ShiZhejiang Jianfeng Pharmaceutical Co Ltd., Jinhua, 321025, People's Republic of China.
Jue MeiClinical Trial Center, Huzhou Central Hospital, Fifth School of Clinical Medicine of Zhejiang Chinese Medical University, Huzhou, 313000, People's Republic of China.
Min XuClinical Trial Center, Huzhou Central Hospital, Fifth School of Clinical Medicine of Zhejiang Chinese Medical University, Huzhou, 313000, People's Republic of China.
Xiang YuClinical Trial Center, Huzhou Central Hospital, Fifth School of Clinical Medicine of Zhejiang Chinese Medical University, Huzhou, 313000, People's Republic of China.
Shuixin YangClinical Trial Center, Huzhou Central Hospital, Fifth School of Clinical Medicine of Zhejiang Chinese Medical University, Huzhou, 313000, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: The study aimed to investigate the pharmacokinetics and bioequivalence of coformulations of valsartan and amlodipine in healthy Chinese subjects under both fasting and fed conditions. Methods: The research was conducted under both fasting and fed studies and employed a single-center, randomized, open-label, single-dose, three-period design with partial-repeat and crossover elements. A total of 71 healthy Chinese adult participants were included under fasting (n = 36) and fed (n = 35) conditions. The subjects were orally administered valsartan/amlodipine tablets (80/5 mg) per cycle either as the test (T) or reference (R) formulation. The washout period was 14 days. Plasma concentrations of valsartan and amlodipine were determined using ultrahigh-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), and the noncompartmental analysis method was used for estimating the pharmacokinetic parameters. Results: Under fasting conditions, the within-subject standard deviations (S Conclusion: The two formulations of valsartan/amlodipine (80/5 mg) tablets were bioequivalent and safe.

Indexed as

AmlodipineAmlodipine, Valsartan Drug CombinationValsartanAdministration, OralAdultChromatography, High Pressure LiquidCross-Over StudiesEast Asian PeopleFemaleHealthy VolunteersHumansMaleTabletsTandem Mass SpectrometryTherapeutic EquivalencyYoung AdultAmlodipineAmlodipine, Valsartan Drug CombinationTabletsValsartanamlodipinebioequivalencepharmacokineticssafetyvalsartan

Identifiers

PMID39781445
PMCPMC11705982

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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.