Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301

HK inno.N

Status and phase: Completed; Phase 3

Conditions: Parenteral Nutrition

Treatments: Drug: RPN301; Drug: IN-C006 Peri inj.

Study type: Interventional

Funder types: Industry

Identifiers

NCT05337228

IN_PPN_301

Details and patient eligibility

About

This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 in postoperative patients requiring central parenteral nutrition.

Full description

This study is a randomized, open-label, phase 3 design. The subject will be assigned to one of the two treatment groups (IN-C006 Peri inj. or RPN301)

Enrollment: 59 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 19 at the time of obtaining the informed consent form
• Requiring over 3 days of parenteral nutrition via a peripheral vein after an operation
• BMI 16 ~ 30 kg/㎡

Exclusion criteria

• Has received parenteral nutrition within 7 days of screening
• Severe dyslipidemia
• Uncontrolled diabetes
• Clinically significant liver disease
• Clinically significant kidney disease

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

IN-C006 Peri inj.

Experimental group

Description:

IN-C006 Peri inj. 1904 mL

Treatment:

Drug: IN-C006 Peri inj.

RPN301

Active Comparator group

Description:

RPN301 2020 mL

Treatment:

Drug: RPN301