Repeated dose study of NPC-25

JRCT ID: jRCT2031210090

Registered date:13/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hypozincemia
• Date of first enrollment: 22/03/2021
• Target sample size: 48
• Study type: Interventional

Intervention(s)

- NPC-25 capsels (50 mg/day) are orally administered once daily for 14 days after meals.
- NPC-25 capsels (100 mg/day) are orally administered once daily for 14 days after meals.
- NPC-25 capsels (50 mg/day) are orally administered twice daily for 14 days after meals.
- NPC-25 capsels (100 mg/day) are orally administered twice daily for 14 days after meals.
- Nobelzin tablets (50 mg/day) are orally administered twice daily for 14 days after meals.
- Nobelzin tablets (100 mg/day) are orally administered twise daily for 14 days after meals.

Outcome(s)

• Primary Outcome: Serum zinc concentration, pharmacokinetic parameters and safety evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 35age old
• Gender: Male

Include criteria

(1) Subjects aged from 20 to 35 years healthy adult Japanese male
(2) Subjects with BMI (body mass index:weight (kg) / height (m) 2 ) of 18.5 or more and less than 25.0
(3) Subjects whose serum zinc concentration at the time of screening test (within 4 weeks before the start of
the clinical trial) is less than 100 microgram / dL
(4) Signature of the subjects on the Informed Consent Form

Exclude criteria

(1) Drug addicts, alcohol addicts.
(2) Subjects with a history of visceral disease or surgery that may affect drug metabolism or excretion.
(3) Subjects who can not keep drinking or smoking cessation during hospitalization.
(4) Subjects with allergies or hypersensitivity to zinc containing preparations (including supplements).
(5) Subjects who have taken zinc containing preparations or zinc containing supplements that are prohibited
from being used in combination within 4 weeks before the start of the clinical trial.
(6) Subjects who participated in other clinical trials within 12 weeks before the start of the clinical trial.
(7) Subjects whose serum copper concentration deviates from the normal standard value range.
(8) Subjects who donated 400 mL or more within 12 weeks, 200 mL or more within 4 weeks, and subjects
who donated component blood within 2 weeks before the start of the clinical trial.
(9) Other patients considered inappropriate by the investigators for inclusion in the study.

Related Information

• Primary Sponsor: Kitamura Motohiro
• Secondary ID(s): Nil known