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Clinical trial

A Randomized, Open-label, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301 in Postoperative Patients Requiring Peripheral Parenteral Nutrition

ID
Name
IN_PPN_301
Description
This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 in postoperative patients requiring central parenteral nutrition.
Trial arms
Trial start
2022-08-09
Estimated PCD
2023-02-10
Trial end
2023-02-24
Status
Completed
Phase
Early phase I
Treatment
IN-C006 Peri inj.
IN-C006 peri inj. will be injected continuously for 3 days.
Arms:
IN-C006 Peri inj.
RPN301
RPN301 will be injected continuously for 3 days.
Arms:
RPN301
Size
59
Primary endpoint
Adverse drug reaction rate
Day 1 to Day 4
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 59, 'type': 'ACTUAL'}}
Updated at
2023-09-28

1 organization

2 products

1 indication

Organization
HK inno.N Corporation
Product
IN-C006
Indication
Parenteral nutrition
Product
RPN301