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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
Phase 1 trial testing Perampanel in Healthy Participants in 24 participants. Completed in 9 March 2018.
9 March 2018
Quick facts
| Lead sponsor | Eisai Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 18 December 2017 |
| Primary completion | 9 March 2018 |
| Estimated completion | 9 March 2018 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Perampanel (PERAMPANEL) — full drug profile →
- Perampanel (PERAMPANEL) — full drug profile →
Conditions studied
- Healthy Participants — all drugs for Healthy Participants →
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):
-
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
Verify or expand the search:
- PubMed search for NCT03399734
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT06401707 — PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest · Phase 2 · recruiting
- NCT04309721 — Perampanel in Focal Status Epilepticus · Phase 3 · terminated
- NCT05533814 — A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizure · Phase 4 · completed
Other recruiting trials for Healthy Participants
Currently open trials in the same condition.
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Other Eisai Co., Ltd. trials
Trials by the same sponsor.
- NCT07515014 — A Study of E6742 in Participants With Systemic Lupus Erythematosus · Phase 2 · not yet recruiting
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- NCT06657378 — A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized T · recruiting
- NCT06322667 — A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab · recruiting
- NCT05633108 — A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03399734 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eisai Co., Ltd.
- Last refreshed: 29 October 2018
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing