Evidence map›Paper›PMID 38771476›Full record

Trial reportAdvances in therapy2024

Pharmacokinetic Comparison of a Fixed-Dose Combination of Candesartan Cilexetil/Amlodipine/Atorvastatin Versus Co-administration of Individual Formulations in Healthy Participants.

Jae Hoon Kim, Ji Hye Song, MinYoung Kim, Jang Hee Hong, Jung Sunwoo, Jin-Gyu Jung

2 registry-linked trialsAbstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this 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.

NCT04478097 phase1unknown statusnot on this map

A Randomized, Open, Single-dose, 3 Period Partial Replicated Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-333 or Co-administration of CKD-330 and D086 in Healthy Volunteers Under Fasting Conditions

TypeinterventionalSponsorChong Kun Dang PharmaceuticalRan2020 to 2021Enrolled51ConditionsCardiovascular DiseaseArmsCKD-330 Tab. and D086 Tab., CKD-333 Tab.
NCT04627207 phase1unknown statusnot on this map

A Randomized, Open, Single-dose, 3 Period Partial Replicated Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-333 or Co-administration of CKD-330 and D085 in Healthy Volunteers Under Fasting Conditions

TypeinterventionalSponsorChong Kun Dang PharmaceuticalRan2020 to 2021Enrolled51ConditionsCardiovascular DiseasesArmsCKD-330 1 Tab. and D085 1 Tab., CKD-333 1 Tab
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

6 authors.

Jae Hoon KimClinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea.ORCID 0000-0001-5643-0913
Ji Hye SongClinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea.ORCID 0000-0002-3952-5096
MinYoung KimPharmaceutical Research and Technology Development Center, Chong Kun Dang Pharmaceutical Corporation, Yongin, Gyeonggi, Republic of Korea.ORCID 0009-0003-8812-412X
Jang Hee HongClinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea.ORCID 0000-0002-0623-5455
Jung Sunwoo *Clinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea. swj4991@cnuh.co.kr.ORCID 0000-0001-8801-0323
Jin-Gyu Jung *Department of Family Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea. jjg72@hanmail.net.ORCID 0000-0002-2591-4867

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFixed-dose combinations (FDCs) of angiotensin II receptor blockers, calcium channel blockers, and statins are conventional therapeutic interventions prescribed for cardiovascular diseases. This study aimed at drawing a comparison between the pharmacokinetics and safety of an FDC and the corresponding individual formulations in healthy subjects.

methodsA randomized, open-label, single-dose, three-sequence, three-period, partially repeated crossover study was conducted with a cohort of healthy volunteers. A 14-day washout period was maintained between each of the three periods. In this study, candesartan cilexetil, amlodipine, and atorvastatin was administered orally as FDCs of 16/10/40 mg in study 1 and 16/5/20 mg in study 2. The maximum plasma concentration (C

resultsThe GMRs (90% CIs) for the AUC

conclusionThe C

trial registrationClinicalTrials.gov identifier, study 1: NCT04478097; study 2: NCT04627207.

Indexed as

AmlodipineAtorvastatinBenzimidazolesBiphenyl CompoundsCross-Over StudiesDrug CombinationsTetrazolesAdultAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsArea Under CurveCalcium Channel BlockersFemaleHealthy VolunteersHeptanoic AcidsHumansAmlodipineAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsAtorvastatinBenzimidazolesBiphenyl CompoundsCalcium Channel Blockerscandesartan cilexetilDrug CombinationsHeptanoic AcidsTetrazolesAmlodipineAtorvastatinCandesartan cilexetilFixed-dose combinationPharmacokinetics

Identifiers

PMID38771476
PMCPMC11213815

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.