Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02321865

Enrollment

Registered

2014-12-22

Start date

2015-01-21

Completion date

2015-11-24

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zinc Deficiency

Brief summary

The objective of this study is to check the dose control method of NPC-02 and the holding effect for the target serum zinc concentration in patients with zinc deficiency.

Interventions

DRUGNPC-02

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* The serum zinc concentrations are under the nomal level before registration * Able to taking a tablet

Exclusion criteria

1. Heavy hepatitis 2. Malignant tumor 3. Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc. 4. The serum albumin under 2.8 g/dL 5. Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement) 6. Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration 7. Pregnant, suspected pregnant, lactating, patients who wish to have a child 8. Patient who participated in other clinical trials within 12 weeks before registration 9. Unsuitable as a target of this clinical trial judged by doctor

Design outcomes

Primary

Measure	Time frame
The ratio of the patients who could maintain target serum zinc concentration	approx. 12-24 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026