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A randomized, open-label, 3-way crossover study to assess the pharmacokinetic drug interactions between DS-8500a and a hypoglycemic agent (glimepiride or repaglinide) in Japanese healthy subjects

A randomized, open-label, 3-way crossover study to assess the pharmacokinetic drug interactions between DS-8500a and a hypoglycemic agent (glimepiride or repaglinide) in Japanese healthy subjects

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223178
Enrollment
36
Registered
2016-04-22
Start date
2016-04-22
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

Sponsors

DAIICHI SANKYO CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Japanese 2)Persons who provided written informed consent before the screening examination 3)Persons >= 20 years and == 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination

Exclusion criteria

Exclusion criteria: 1)Persons with hypersensitivity or idiosyncratic reactions to a drug, (such as penicillin allergy) 2)Persons with drug or alcohol dependence

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics and safety

Outcome results

None listed

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