A bioequivalence study of DS-5565 (mirogabalin besilate) OD tablet

A bioequivalence study of DS-5565 (mirogabalin besilate) - Evaluation of bioequivalence between milogabalin 15 mg tablet and DS-5565 15 mg orally disintegrating (OD) tablet in healthy Japanese subjects -

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080225061

Enrollment

Registered

2020-02-12

Start date

2020-06-11

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 volunteers

Interventions

investigational material(s) Generic name etc : Mirogabalin besilate INN of investigational material : Mirogabalin Therapeutic category code : 119 Other agents affecting central nervous system Dosage a

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Japanese male 2) Aged 20 years to 45 years (inclusive), at the time of informed consent 3) Body mass index (BMI; calculated by body weight [kg]/height [m]2) in the range of >= 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination

Exclusion criteria

Exclusion criteria: 1) Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy) 2) Presence or history of any drug abuse or of alcohol abuse etc.

Design outcomes

Primary

Measure	Time frame
bioequivalence pharmacokinetics Pharmacokinetic parameters of DS-5565 free base (mirogabalin) in the plasma bioequivalence assessment: Cmax, AUClast	—

Secondary

Measure	Time frame
safety pharmacokinetics Pharmacokinetics: Pharmacokinetic parameters of mirogabalin in the plasma Reference parameters: AUCinf, Tmax, MRTinf, Kel Other parameters: t1/2, CL/F, Vz/F, AUCall Safety: adverse event, clinical examination, weight, vital signs (blood pressure, pulse rate, temperature), 12-lead electrocardiogram	—

Countries

Japan

Outcome results

None listed

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