Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require Parenteral Nutrition

A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 Versus NTCB-C in Patients Who Require Parenteral Nutrition

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06625957

Enrollment

Registered

2024-10-03

Start date

2024-12-04

Completion date

2025-07-18

Last updated

2025-01-07

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

Conditions

Parenteral Nutrition

Brief summary

A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 versus NTCB-C in patients who require parenteral nutrition

Interventions

DRUGNTCB02-1

3 Days infusion

DRUGNTCB-C

3 Days infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Those who are 19 years old or older at the screening visit * Patients are expected to require PN for more than 3 days * Patients who voluntarily signed the consent form

Exclusion criteria

* Patients are expected difficult to survive more than 3 days * Patients BMI is over 30 kg/m2 * Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug * Patients with difficult central venous line * Patients judged to be unsuitable for this trial by investigators

Design outcomes

Primary

Measure	Time frame
Occurance rate of adverse drug reaction	Day 1 to day 4

Countries

South Korea

Contacts

Primary ContactJinhyun Choi

clinicaltrials@yuhan.co.kr8228280850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026