Phase I study of DS-7113b

DS-7113b Phase I study -Evaluation of the safety, tolerability and pharmacokinetics of DS-7113b, and the effect of food on the pharmacokinetics of DS-7113b after a single dose of DS-7113b (immediate and extended release formulations) in healthy male Japanese subjects-

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222121

Enrollment

Registered

2013-06-19

Start date

2013-06-19

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-7113b INN of investigational material : Hydromorphone hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administra

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: -Male Japanese -Between the age of 20 and 45 -Between the BMI of 18.5 and 25.0

Exclusion criteria

Exclusion criteria: -Presence or history of severe adverse reaction or sensitivity to any drug. -Presence or history of drug or alcohol abuse. etc.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters for free form and metabolites	—

Outcome results

None listed

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