Clinical Pharmacology Study of DS-5058b Immediate-release and Extended-release Tablets in Healthy Japanese Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080223551

Enrollment

Registered

2017-06-05

Start date

2017-06-14

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 hydrate Therapeutic category code : 811 Opium alkaloids preparations Dosage and Admini

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