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

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Zinc Deficiency

Treatments: Drug: NPC-02

Study type: Interventional

Funder types: Industry

Identifiers

NCT02321865

NPC-02-5

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

NPC-02

Experimental group

Treatment:

Drug: NPC-02