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

Nobelpharma Co., Ltd. logo

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)

43 participants in 1 patient group

NPC-02
Experimental group
Treatment:
Drug: NPC-02

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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