Evidence map›Paper›PMID 37440782›Full record

ArticleTranslational and clinical pharmacology2023

Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects.

Hae Won Lee, Woo Youl Kang, Ji Seo Park, Jae Hwa Lee, Mi-Ri Gwon, Dong Heon Yang, Eun Hee Kim, Soo-Jin Park, Young-Ran Yoon, Sook Jin Seong

Open access · diamondAbstract read
In one paragraph

Article in Translational and clinical pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 43% of its field
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

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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 at 4 institutions in 1 country.

Hae Won LeeSchool of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41944, Korea.ORCID https://orcid.org/0000-0001-7299-5332
Woo Youl KangClinical Trial Dossier Evaluation Team, Department of Innovative Products Support, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Korea.ORCID https://orcid.org/0000-0002-3190-3451
Ji Seo ParkSchool of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41944, Korea.
Jae Hwa LeeSchool of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41944, Korea.
Mi-Ri GwonSchool of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41944, Korea.ORCID https://orcid.org/0000-0001-5703-1615
Dong Heon YangDivision of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu 41944, Korea.
Eun Hee KimCollege of Nursing, Catholic University of Daegu, Gyeongsan 38430, Korea.
Soo-Jin ParkCollege of Korean Medicine, Daegu Haany University, Daegu 38610, Korea.
Young-Ran YoonSchool of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41944, Korea.ORCID https://orcid.org/0000-0003-2166-7579
Sook Jin SeongSchool of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41944, Korea.ORCID https://orcid.org/0000-0001-8872-3796
Kyungpook National University Hospital · KRDaegu Catholic University · KRDaegu Haany University · KRNational Institute of Food and Drug Safety Evaluation · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Two open-label, randomized, two-period crossover studies were conducted to investigate the pharmacokinetic (PK) properties, safety, and bioequivalence of the test formulation (KD4004), a new fixed-dose combination (FDC) formulation of dapagliflozin and metformin extended release (XR) tablets, relative to the reference formulation (10 mg dapagliflozin/1,000 mg metformin XR FDC tablet) in healthy subjects under fasting (Part A) and fed (Part B) conditions. After giving the dose, serial blood samples were collected for a period of 48 hours. Primary PK parameters (AUC Trial Registration: Clinical Research Information Service Identifier: KCT0004026.

Indexed as

BioequivalenceDapagliflozinFixed-Dose CombinationMetformin Extended ReleaseType 2 Diabetes

Identifiers

PMID37440782
PMCPMC10333646
OpenAlexW4383111458

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.