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An Open-label, Single-center, Drug-drug Interaction Study to Assess the Effect of SK-0403 on the Pharmacokinetics, Pharmacodynamics and Safety of Multiple Oral Administration of Metformin in Japanese Patients With Type 2 Diabetes

An Open-label, Single-center, Drug-drug Interaction Study to Assess the Effect of SK-0403 on the Pharmacokinetics, Pharmacodynamics and Safety of Multiple Oral Administration of Metformin in Japanese Patients With Type 2 Diabetes

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221200
Enrollment
18
Registered
2010-08-12
Start date
2010-08-12
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

Type 2 diabetes mellitus

Interventions

investigational material(s) Generic name etc : SK-0403 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : O

Sponsors

SANWA KAGAKU KENKYUSHO Co., Ltd.
Lead Sponsor
Kowa Company, Ltd.
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus who have inadequate glycemic control by diet and/or exercise therapies HbA1C of >= 6.5%, but < 10.0% measured during the run-in period

Exclusion criteria

Exclusion criteria: Patients with type 1 diabetes mellitus Patients with, or a history of, clinically significant cardiac, renal, hepatic, pulmonary, pancreatic and macrovascular disease Patients who had taken SK-0403 or metformin

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics, Pharmacodynamics and Safety—

Outcome results

None listed

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