Evidence map›Paper›PMID 41332264›Full record

Trial reportClinical and translational science2025

Assessment of Pharmacokinetics and Food Effect of AD-109, a Novel Formulation of Rivaroxaban 18 mg.

Hyunwook Ryu, Joo-Youn Cho, Taewon Lee, Jandee Kim, SeungHwan Lee

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Trial
  2. 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

5 authors.

Hyunwook RyuDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
Joo-Youn ChoDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.ORCID 0000-0001-9270-8273
Taewon LeeAddpharma Co., Ltd, Seongnam-si, Gyeonggi-do, Republic of Korea.
Jandee KimAddpharma Co., Ltd, Seongnam-si, Gyeonggi-do, Republic of Korea.
SeungHwan LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.ORCID 0000-0002-1713-9194

Funding

Addpharma Co. Ltd.Ministry of Trade Industry & Energy (MOTIE, Korea)Yuhan Corporation
6 · The paper itself

Abstract

Rivaroxaban is an oral anticoagulant that requires food intake at high doses (15 and 20 mg) due to a pronounced food effect. AD-109 is a novel formulation of rivaroxaban 18 mg, designed to enhance oral bioavailability and mitigate the food effect. This study aimed to evaluate the pharmacokinetics (PKs) of AD-109 compared to the conventional formulation, Xarelto (Xarelto, rivaroxaban 20 mg) and the effect of food on the PK of AD-109. Two open-label, single-dose, two-period, two-sequence crossover studies were conducted. In Study 1, participants received a single dose of AD-109 and Xarelto under fed state, while in Study 2, participants received a single dose of AD-109 under fed and fasted state. Serial blood samples were collected up to 34 h post-dose and PK parameters were calculated by non-compartmental method. In both studies, 33 out of 36 volunteers completed the study. The geometric mean ratios (GMRs) and their 90% confidence intervals (CIs) for the maximum plasma concentration (C

Indexed as

Factor Xa InhibitorsFood-Drug InteractionsRivaroxabanAdministration, OralAdultArea Under CurveBiological AvailabilityCross-Over StudiesFastingFemaleHealthy VolunteersHumansMaleMiddle AgedYoung AdultFactor Xa InhibitorsRivaroxabancardiovascular diseaseclinical trialsformulationpharmacokineticsphase I

Identifiers

PMID41332264
PMCPMC12673223

What OpenQuestion holds

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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.