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NCT03399734

Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

Completed Phase 1 Last updated 29 October 2018
What this trial tests

Phase 1 trial testing Perampanel in Healthy Participants in 24 participants. Completed in 9 March 2018.

Timeline
18 December 2017
Primary endpoint
9 March 2018
9 March 2018

Quick facts

Lead sponsorEisai Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposebasic science
Enrollment24
Start date18 December 2017
Primary completion9 March 2018
Estimated completion9 March 2018
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Eisai Co., Ltd. — full company profile →

Who can join

Adults 20 to 45, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Bioequivalence of perampanel fine granules and tablets in healthy Japanese subjects.
    Shiba S, Sekino H, Ishiba K, Yasuda S, et al · · 2020 · cited 4× · PMID 32870153 · DOI 10.5414/cp203781

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Other trials of Perampanel

Trials testing the same drug.

Other recruiting trials for Healthy Participants

Currently open trials in the same condition.

Other Eisai Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03399734.

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