A Bioequivalence study of DS-5058b (immediate-release tablet) and oxycodone hydrochloride hydrate in healthy Japanese subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080223737

Enrollment

Registered

2017-11-30

Start date

2017-12-12

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 : DS-5058b INN of investigational material : Oxycodone Hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administration

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Japanese male - Between the age of 20 and 45 - Persons with a body mass index (BMI; calculated by body weight [kg]/height [m]2) of >= 18.5 kg/m2 and < 25.0 kg/m2

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
pharmacokinetics - Pharmacokinetics	—

Secondary

Measure	Time frame
safety - Safety	—

Countries

Japan

Outcome results

None listed

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