Evidence map›Paper›PMID 40444644›Full record

Trial reportClinical pharmacology in drug development2025

Bioequivalence of a Donepezil/Memantine 10/20 mg Fixed-Dose Combination Versus Single-Component Tablets in Healthy Korean Males.

Minkyu Choi, Byung Hak Jin, Do Hoon Keum, Kyoung Hoon Mo, Min Soo Park, Juhwan Lee, Sungjin Park, Choon Ok Kim

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Clinical pharmacology in drug development, 2025. 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
–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

0 citing papers in PubMed.

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

8 authors.

Minkyu ChoiDepartment of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Byung Hak JinDepartment of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Do Hoon KeumDepartment of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Kyoung Hoon MoDepartment of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Min Soo ParkDepartment of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Juhwan LeeDepartment of Clinical Research, Hyundai Pharmaceutical Co. Ltd., Seoul, South Korea.
Sungjin ParkDepartment of Clinical Research, Hyundai Pharmaceutical Co. Ltd., Seoul, South Korea.
Choon Ok KimDepartment of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A fixed-dose combination (FDC) tablet formulation of donepezil/memantine (10/20 mg) was developed to improve medication compliance in patients with Alzheimer's disease (AD). This study compared the pharmacokinetic (PK) characteristics and safety profiles of an FDC formulation (donepezil/memantine [10/20 mg]) and single components (SCs) of donepezil (10 mg) and memantine (20 mg). In a randomized, open-label, single-dose, 2-way crossover study, 24 healthy Korean participants received a single oral dose of FDC in 1 period and an SC of donepezil and memantine in another period. For PK analysis, blood samples were collected up to 240 hours after administration. The geometric mean ratios and their 90% confidence intervals for the main PK parameters (C

Indexed as

Cholinesterase InhibitorsDonepezilMemantineAdministration, OralAdultArea Under CurveCross-Over StudiesDrug CombinationsHealthy VolunteersHumansMaleRepublic of KoreaTabletsTherapeutic EquivalencyYoung AdultCholinesterase InhibitorsDonepezilDrug CombinationsMemantineTabletsAlzheimer's diseasedonepezilfixed‐dose combinationmemantine

Identifiers

PMID40444644
PMCPMC12402880

What OpenQuestion holds

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LicenceCC BY
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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.