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DK-233(Rifampicin) Bioequivalence study -Bioequivalence of DK-233 150 mg capsules and DK-233 20 mg/ml syrup in healthy Japanese subjects-

DK-233(Rifampicin) Bioequivalence study -Bioequivalence of DK-233 150 mg capsules and DK-233 20 mg/ml syrup in healthy Japanese subjects-

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080223619
Enrollment
12
Registered
2017-08-18
Start date
2017-08-18
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 : DK-233 syrup INN of investigational material : rifampicin Therapeutic category code : 616 Antibiotic preparations acting mainly on acid-fast bacteria Dos

Sponsors

DAIICHI SANKYO CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1)Japanese male 2)Aged 20 years to 45 years (inclusive), at the time of informed consent 3)Body mass index (BMI; calculated by body weight [kg]/height [m]2) in the range of >= 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination

Exclusion criteria

Exclusion criteria: 1)Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy) 2)Presence or history of any drug abuse or of alcohol abuse etc.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics and safety

Outcome results

None listed

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