Pharmacokinetic properties of the zinc agent polaprezinc in subjects with zinc deficiency

JRCT ID: jRCT2080221593

Registered date:22/09/2011

Basic Information

• Health condition(s) or Problem(s) studied: male subjects
• Date of first enrollment: 22/09/2011
• Target sample size: 6
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : Z-103
INN of investigational material : polaprezinc
Therapeutic category code : 232 Agents for peptic ulcer
Dosage and Administration for Investigational material : a single dose of oral polaprezinc (75 mg, containing 17 mg of zinc) was administered with 150 mL water to subjects who fasted 12 hours before dosing

Outcome(s)

Primary Outcome

plasma zinc concentration
N/A

Secondary Outcome

N/A
N/A

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Male

Include criteria

- subjects with low serum zinc concentrations (<70 microgram /dL)
- subjects with a body mass indexes (BMI) ranging from 18.5 to 25.0

Exclude criteria

- Subjects allergic to zinc, with abnormal hepatic, renal, or cardiac function, drug or alcohol dependence, tobacco use, or acute or chronic disorders that might interfere with drug absorption
- Subjects who received any medication within the 7 days prior to the date of drug administration

Related Information

• Primary Sponsor: Zeria Pharmaceutical Co., Ltd.
• Secondary Sponsor: N/A
• Secondary ID(s): JapicCTI-111633