A Bioequivalence Study of CS-3150 (esaxerenone) OD tablet

A Bioequivalence Study of CS-3150 - Evaluation of bioequivalence between esaxerenone 5 mg tablet and esaxerenone 5 mg OD tablet (CS-3150 OD tablet) in healthy Japanese subjects -

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080224760

Enrollment

Registered

2019-07-02

Start date

2019-07-30

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 : esaxerenone INN of investigational material : esaxerenone Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigationa

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Japanese male - Aged >= 20 years and = 18.5 kg/m2 and < 25.0 kg/m2 at screening - Sitting systolic BP < 140 mmHg and diastolic BP < 90 mmHg at screening - Pulse rate <= 99 bpm at screening

Exclusion criteria

Exclusion criteria: - Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy) - People with drug or alcohol dependence etc.

Design outcomes

Primary

Measure	Time frame
bioequivalence Cmax, AUClast	—

Secondary

Measure	Time frame
safety pharmacokinetics Safety: adverse events, clinical laboratory tests, body weight, vital signs, and 12-lead electrocardiograms Pharmacokinetics: AUCinf, Tmax, MRTinf, Kel, t1/2, CL/F, Vz/F	—

Countries

Japan

Outcome results

None listed

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