Evidence map›Paper›PMID 29559771›Full record

Trial reportDrug design, development and therapy2018

Pharmacokinetic and bioequivalence study of a telmisartan/S-amlodipine fixed-dose combination (CKD-828) formulation and coadministered telmisartan and S-amlodipine in healthy subjects.

Woo Youl Kang, Sook Jin Seong, Boram Ohk, Mi-Ri Gwon, Bo Kyung Kim, Sookie La, Hyun-Ju Kim, Seungil Cho, Young-Ran Yoon, Dong Heon Yang and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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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

11 authors.

Woo Youl Kang *Clinical Trial Center, Kyungpook National University Hospital, Daegu, Republic of Korea.
Sook Jin Seong *Clinical Trial Center, Kyungpook National University Hospital, Daegu, Republic of Korea.
Boram OhkClinical Trial Center, Kyungpook National University Hospital, Daegu, Republic of Korea.
Mi-Ri GwonClinical Trial Center, Kyungpook National University Hospital, Daegu, Republic of Korea.
Bo Kyung KimClinical Trial Center, Kyungpook National University Hospital, Daegu, Republic of Korea.
Sookie LaAnalytical Research Division, Biocore Co Ltd, Seoul, Republic of Korea.
Hyun-Ju KimDepartment of Molecular Medicine, Cell and Matrix Research Institute, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
Seungil ChoClinical Trial Center, Kyungpook National University Hospital, Daegu, Republic of Korea.
Young-Ran YoonClinical Trial Center, Kyungpook National University Hospital, Daegu, Republic of Korea.
Dong Heon YangDivision of Cardiology, Department of Internal Medicine, Kyungpook National University School of Medicine & Hospital, Daegu, Republic of Korea.
Hae Won LeeClinical Trial Center, Kyungpook National University Hospital, Daegu, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA new fixed-dose combination (FDC) formulation of telmisartan 80 mg and S-amlodipine 5 mg (CKD-828) has been developed to increase convenience (as only one tablet is required per day) and improve treatment compliance.

methodsThe pharmacokinetic characteristics and tolerability of an FDC of telmisartan and S-amlodipine were compared to those after coadministration of the individual agents in this randomized, open-label, single-dose, two-way, four-period, crossover study. To analyze the telmisartan and S-amlodipine plasma concentrations using a validated liquid chromatography-tandem mass spectrometry method, serial blood samples were collected up to 48 hours post-dose for telmisartan and 144 hours post-dose for S-amlodipine, in each period.

resultsForty-eight healthy subjects were enrolled, and 43 completed the study. The mean peak plasma concentration (C

conclusionCKD-828 FDC tablets were shown to be bioequivalent to coadministration of the individual agents with the respective strength, in healthy subjects under fasting conditions. There was no significant difference in safety profile between the two treatments.

Indexed as

AdultAmlodipineBenzimidazolesBenzoatesChromatography, LiquidCross-Over StudiesDose-Response Relationship, DrugDrug CombinationsDrug ToleranceHealthy VolunteersHumansMaleMiddle AgedMolecular StructureStructure-Activity RelationshipTabletsAmlodipineBenzimidazolesBenzoatesDrug CombinationsTabletsTelmisartanfixed-dose combinationpharmacokineticssafetyS-amlodipinetelmisartan

Identifiers

PMID29559771
PMCPMC5857156

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Registered trials

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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.