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A pilot cross-over bioequivalence study of E3810 for healthy Japanese male

A pilot cross-over bioequivalence study of E3810 for healthy Japanese male

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080221223
Enrollment
16
Registered
2010-09-01
Start date
2010-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy Japanese male

Interventions

investigational material(s) Generic name etc : E3810 INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material :

Sponsors

Eisai Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Subjects with homozygous or hetrozygous extensive metabolizers of cytochrome P4502C19.

Exclusion criteria

Exclusion criteria: Subjects with allergy

Design outcomes

Primary

MeasureTime frame
The following Pharmacokinetic parameters are calculated; The Maximum drug Concentration (Cmax) in plasma. Area under the plasma Concentration time Curve.—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026