Evidence map›Paper›PMID 36932300›Full record

ArticleNeurology and therapy2023

Comparative Bioequivalence of Tablet and Capsule Formulations of Ulotaront and the Effect of Food on the Pharmacokinetics of the Tablet Form in Humans.

Yu-Luan Chen, Hironobu Tsukada, Snezana Milanovic, Lei Shi, Yan Li, Yongcai Mao, Kenneth S Koblan, Gerald R Galluppi

Open access · goldAbstract read
In one paragraph

Article in Neurology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 35% 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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. CPhaMAS: The first pharmacokinetic analysis cloud platform developed by China.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Article
  3. Article
  4. Review
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 at 2 institutions in 2 countries.

Yu-Luan ChenSunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA. yu-luan.chen@sunovion.com.ORCID http://orcid.org/0000-0002-2866-3602
Hironobu TsukadaSunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.
Snezana MilanovicSunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.
Lei ShiSunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.
Yan LiSunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.
Yongcai MaoSunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.
Kenneth S KoblanSunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.
Gerald R GalluppiSunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.
Sunovion (United States) · USSunovion (United Kingdom) · GB

Funding

Sunovion Not available
6 · The paper itself

Abstract

introductionUlotaront (SEP-363856), a dual trace animeassociated receptor 1 (TAAR1) and 5-HT

methodsThe BE study applied an open-label two-period crossover design in 24 healthy volunteers. Subjects were randomly assigned (1:1) to dosing sequence AB or BA (A, 25 mg ulotaront tablet; B, 25 mg ulotaront capsule). The FE study also used an open-label randomized two-period crossover design in 20 healthy volunteers. Subjects were fasted overnight then randomly assigned (1:1) to dosing sequence AB or BA (A, fasted condition; B, fed condition). Dosing periods were separated by 1 week for both studies. Serial plasma samples from each period were collected and analyzed by LC-MS/MS. PK parameters were calculated using Phoenix WinNonlin

resultsFor the BE study, geometric mean ulotaront C

conclusionsThe results showed geometric mean ratios and 90% CIs for both C

Indexed as

Comparative bioequivalenceFood effectLC–MS/MSN-Desmethyl metabolitePharmacokineticsUlotaront (SEP-363856)

Identifiers

PMID36932300
PMCPMC10195965
OpenAlexW4327712977

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.