A Phase 3 interventional study of IN-C006 inj. and RCN301 in Parenteral Nutrition, sponsored by HK inno.N Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by HK inno.N Corporation · Phase 3, Interventional, and Supportive care
This study is designed to evaluate the safety and efficacy of IN-C006 inj. and RCN301 in postoperative patients requiring central parenteral nutrition.
This study is a randomized, open-label, phase 3 design. The subject will be assigned to one of the two treatment groups (IN-C006 inj. or RCN301)
HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IN-C006 inj. 1970 mL
Drug: IN-C006 inj.
RCN301 1820 mL
Drug: RCN301
IN-C006 will be injected continuously for 3 days.
Also known as: IN-C006 inj
RCN301 will be injected continuously for 3 days.
Adverse drug reaction rate
Rate of treatment-related adverse events as assessed by CTCAE v5.0 and investigator's evaluation
Time frame: Day 1 to Day 4
Change in nutritional management parameters
Nitrogen balance(Nitrogen intake-Nitrogen out), Prealbumin(mg/L), Albumin(g/dL), Transferrin(mg/dL)
Time frame: Day 1 to Day 4
Change in inflammation parameters
hs-CRP(mg/L), TNF-α(pg/mL), IL-6(pg/mL)
Time frame: Day 1 to Day 4
Change in fatty acid profile
LA(ug/mL), AA(ug/mL), EPA(ug/mL), DHA(ug/mL)
Time frame: Day 1 to Day 4
Incidence of Adverse event
Rate of adverse events as assessed by CTCAE v5.0 and investigator's evaluation
Time frame: Day 1 to Day 4
Change in laboratory parameters
Hematology, Blood chemistry, Blood coagulation test, Urinalysis
Time frame: Day 1 to Day 4
Change in vital sign
Blood pressure(mmHg), pulse rate(rate), body temperature(℃) and respiratory rate(rate)
Time frame: Day 1 to Day 4
Normal and abnormal change in physical examination
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
Time frame: Day 1 to Day 4
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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HK inno.N Corporation