DS-5058b (extended-release tablet) bioequivalence study

Bioequivalence of DS-5058b (extended-release tablet) to oxycodone hydrochloride hydrate in healthy Japanese subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080223420

Enrollment

Registered

2016-12-22

Start date

2014-03-31

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: - Male Japanese - Between the age of 20 and 45 - Between the BMI of 18.5 and 24.9

Exclusion criteria

Exclusion criteria: - Presence or history of hypersensitivity or idiosyncratic reaction (penicillin allergy etc.) to a drug. - Presence or history of 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