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Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 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 NTCB01-1 Versus NTCB-P in Patients Who Require Parenteral Nutrition

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06625931
Enrollment
60
Registered
2024-10-03
Start date
2024-11-14
Completion date
2025-03-28
Last updated
2025-05-15

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 NTCB01-1 versus NTCB-P in patients who require parenteral nutrition

Interventions

DRUGNTCB01-1

3 Days infusion

DRUGNTCB-P

3 Days infusion

Sponsors

Yuhan Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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 peripheral intravenous line * Patients judged to be unsuitable for this trial by investigators

Design outcomes

Primary

MeasureTime frame
Occurance rate of adverse drug reactionDay 1 to day 4

Countries

South Korea

Outcome results

None listed

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