NIPH Clinical Trials Search

Clinical Pharmacology Study of NS-229 in Healthy adult male subjects (Phase I Study) (Drug-Drug Interaction Study with Omeprazole, Fexofenadine and Rosuvastatin)

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Healthy volunteer
Date of first enrollment	28/02/2026
Target sample size	55
Countries of recruitment
Study type	Interventional
Intervention(s)	Step 1 Day 1, 19: Omeprazole, Fexofenadine and Rosuvastatin will be orally administered in single dose. Day 6-Day 21: NS-229 will be orally administered in multiple doses. Step 2 Day 1, 9: NS-229 will be orally administered in single dose. Day 3-Day 8: Omeprazole will be orally administered in multiple doses. Day 9: Omeprazole will be orally administered in single dose.

Outcome(s)

Primary Outcome	PK parameters (AUC and Cmax) of NS-229 and combination drugs (Omeprazole, Fexofenadine and Rosuvastatin).
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 45age old
Gender	Male
Include criteria	1) Provided written informed consent 2) Japanese male subjects 3) Body mass index (BMI) >=18.5 and <25.0 kg/m2 at the time of screening tests and hospitalization
Exclude criteria	1) Subjects with a history of surgery which may have an impact on drug absorption 2) Subjects with a history of allergy or hypersensitivity to drugs or foods 3) Subjects who collected 200 mL or more of whole blood or component blood within 2 weeks before administration of the study drug 4) Subjects who have received other investigational products within 16 weeks (112 days) prior to the first investigational product administration