Evidence map›Paper›PMID 41998831›Full record

Trial reportClinical pharmacology in drug development2026

Bioequivalence and Safety Assessment of Brivaracetam Dry Syrup Compared With Tablets in Healthy Japanese Participants: Results From Two Randomized Single- and Multiple-Dose Trials.

Yoshinobu Hayakawa, Ryoji Yoshinaka, Tomonobu Sano, Walter Krauwinkel, Tadaharu Soma, Hiroshi Sasamoto, Jan-Peer Elshoff, Almasa Bass, Ying Chen, Nozomi Kurihara and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05315947 (A Single-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants), which is not on this 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.

NCT05315947 phase1completednot on this map

A Single-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants

TypeinterventionalSponsorUCB Biopharma SRLRan2022 to 2022Enrolled24ConditionsHealthy Study ParticipantsArmsbrivaracetam
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

11 authors.

Yoshinobu HayakawaUCB, Tokyo, Japan.
Ryoji YoshinakaUCB, Tokyo, Japan.
Tomonobu SanoUCB, Tokyo, Japan.
Walter KrauwinkelUCB, Braine-l'Alleud, Belgium.
Tadaharu SomaUCB, Tokyo, Japan.
Hiroshi SasamotoUCB, Tokyo, Japan.
Jan-Peer ElshoffUCB, Monheim am Rhein, Germany.
Almasa BassUCB, Morrisville, NC, USA.
Ying ChenUCB, Shanghai, China.
Nozomi KuriharaUCB, Tokyo, Japan.
Harumi MurakamiSouseikai Sumida Hospital, Sumida-City, Tokyo, Japan.

Funding

UCB
6 · The paper itself

Abstract

The antiseizure medication brivaracetam is available as tablets, oral solution, and solution for intravenous injection in many countries. A dry syrup formulation is being developed for use in Japan. We report two phase 1, single-center, open-label, randomized, two-way crossover trials that assessed bioequivalence, safety, and tolerability of brivaracetam dry syrup and tablet formulations in healthy adult male Japanese participants. EP0110 (NCT05315947) assessed brivaracetam 50 mg dry syrup versus tablet after a single administration (N = 24). Although pharmacokinetic profiles were similar and bioequivalence criteria for AUC were met, bioequivalence criteria for the observed C

Indexed as

AnticonvulsantsPyrrolidinonesAdministration, OralAdultArea Under CurveCross-Over StudiesEast Asian PeopleHealthy VolunteersHumansJapanMaleMiddle AgedTabletsTherapeutic EquivalencyYoung AdultAnticonvulsantsbrivaracetamPyrrolidinonesTabletsadverse eventsanticonvulsantsclinical trialspharmacokineticsphase I

Identifiers

PMID41998831
PMCPMC13090423

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.