Parenteral Nutrition
Conditions
Brief summary
This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 in postoperative patients requiring central parenteral nutrition.
Detailed 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)
Interventions
DRUGIN-C006 Peri inj.
IN-C006 peri inj. will be injected continuously for 3 days.
DRUGRPN301
RPN301 will be injected continuously for 3 days.
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse drug reaction rate | Day 1 to Day 4 | Rate of treatment-related adverse events as assessed by CTCAE v5.0 and investigator's evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in nutritional management parameters(Nitrogen balance) | Day 1 to Day 4 | Nitrogen balance(Nitrogen intake-Nitrogen out) |
| Change in nutritional management parameters(Prealbumin) | Day 1 to Day 4 | Prealbumin(mg/L) |
| Change in nutritional management parameters(Albumin) | Day 1 to Day 4 | Albumin(g/dL) |
| Change in nutritional management parameters(Transferrin) | Day 1 to Day 4 | Transferrin(mg/dL) |
| Change in inflammation parameters(hs-CRP) | Day 1 to Day 4 | hs-CRP(mg/L) |
| Change in inflammation parameters(TNF-α) | Day 1 to Day 4 | TNF-α(pg/mL) |
| Change in inflammation parameters(IL-6) | Day 1 to Day 4 | IL-6(pg/mL) |
| Change in fatty acid profile | Day 1 to Day 4 | LA(ug/mL), AA(ug/mL), EPA(ug/mL), DHA(ug/mL) |
| Incidence of Adverse event | Day 1 to Day 4 | Rate of adverse events as assessed by CTCAE v5.0 and investigator's evaluation |
| Change in laboratory parameters (Hematology) | Day 1 to Day 4 | Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group \- Hematology |
| Change in laboratory parameters (Blood coagulation test) | Day 1 to Day 4 | Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group \- Blood coagulation test |
| Change in laboratory parameters (Urinalysis) | Day 1 to Day 4 | Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group \- Urinalysis |
| Change in vital sign (Blood pressure) | Day 1 to Day 4 | Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) \- Systolic blood pressure(mmHg), Diastolic blood pressure(mmHg) |
| Change in vital sign (Pulse rate) | Day 1 to Day 4 | Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) \- Pulse rate(rate) |
| Change in vital sign (Body temperature) | Day 1 to Day 4 | Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) \- Body temperature(℃) |
| Change in vital sign (Respiratory rate) | Day 1 to Day 4 | Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) \- Respiratory rate(rate) |
| Normal and abnormal change in physical examination (Frequency) | Day 1 to Day 4 | Frequency of subjects who were normal/clinically insignificant abnormalities before administration of investigational products to clinically significant abnormalities at least once after administration of investigational products \- General Appearance, HEENT (Head, Eyes, Ears, Nose, Throat), Skin (including hair, nails), Respiratory, Cardiovascular, Chest/Lungs/Breast, Abdominal/Gastrointestinal, Musculoskeletal, Extremities/Joint, Neurological/Psychological, Lymph nodes, Rectal/Pelvic/Genitalia, Other |
| Normal and abnormal change in physical examination (Ratio) | Day 1 to Day 4 | Ratio of subjects who were normal/clinically insignificant abnormalities before administration of investigational products to clinically significant abnormalities at least once after administration of investigational products \- General Appearance, HEENT (Head, Eyes, Ears, Nose, Throat), Skin (including hair, nails), Respiratory, Cardiovascular, Chest/Lungs/Breast, Abdominal/Gastrointestinal, Musculoskeletal, Extremities/Joint, Neurological/Psychological, Lymph nodes, Rectal/Pelvic/Genitalia, Other |
| Change in laboratory parameters (Blood chemistry) | Day 1 to Day 4 | Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group \- Blood chemistry |
Countries
South Korea
Outcome results
None listed