Evidence map›Paper›PMID 42321496›Full record

Trial reportClinical drug investigation2026

Assessment of Dose Proportionality and the Effect of Food on a Once-Daily Extended-Release Tablet Formulation of Deutetrabenazine in Healthy Participants.

Eva-Maria Sunzel, Giulia Ghibellini, Maria Gutierrez, Debra Ruffo, Shailendra Chavan, Nagnath G Birajdar, Frank Schneider, Pippa Loupe, Mark Forrest Gordon, Laura Rabinovich-Guilatt

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2026. 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

10 authors.

Eva-Maria SunzelInnovative Medicines R&D Global Clinical Development, Teva Pharmaceuticals, 145 Brandywine Parkway, West Chester, PA, 19380, USA.
Giulia GhibelliniInnovative Medicines R&D Global Clinical Development, Teva Pharmaceuticals, 145 Brandywine Parkway, West Chester, PA, 19380, USA.
Maria GutierrezTeva Clinics, Miramar, FL, USA.
Debra RuffoInnovative Medicines R&D Global Clinical Development, Teva Pharmaceuticals, 145 Brandywine Parkway, West Chester, PA, 19380, USA.
Shailendra ChavanWatson Pharma Pvt. Ltd. Seawoods, Navi-Mumbai, Maharashtra, India.
Nagnath G BirajdarWatson Pharma Pvt. Ltd. Seawoods, Navi-Mumbai, Maharashtra, India.
Frank SchneiderTeva Pharmaceutical Industries Ltd, Ratiopharm GmbH, Ulm, Germany.
Pippa LoupeInnovative Medicines R&D Global Clinical Development, Teva Pharmaceuticals, 145 Brandywine Parkway, West Chester, PA, 19380, USA. Pippa.Loupe@Tevapharm.com.ORCID http://orcid.org/0000-0002-2161-5050
Mark Forrest GordonInnovative Medicines R&D Global Clinical Development, Teva Pharmaceuticals, 145 Brandywine Parkway, West Chester, PA, 19380, USA.
Laura Rabinovich-GuilattInnovative Medicines R&D Global Clinical Development, Teva Pharmaceuticals, Netanya, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveDeutetrabenazine is approved as a treatment in adults for tardive dyskinesia and chorea associated with Huntington's disease. A once-daily tablet (Austedo XR

methodsIn a randomized cross-over study of dosage strength proportionality, healthy participants (n = 116) received single doses of the once-daily deutetrabenazine formulation and a power model was fitted to describe the relationship between dose and pharmacokinetic parameters (maximum observed plasma drug concentration [C

conclusionsThe once-daily formulation of deutetrabenazine exhibited dosage strength proportional pharmacokinetics for doses up to 48 mg and there was no observed effect of food.

Indexed as

Food-Drug InteractionsTetrabenazineAdolescentAdultArea Under CurveCross-Over StudiesDelayed-Action PreparationsDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansMaleMiddle AgedTabletsYoung AdultDelayed-Action PreparationsdeutetrabenazineTabletsTetrabenazine

Identifiers

PMID42321496
PMCPMC13356046

What OpenQuestion holds

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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.