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A Prospective, Randomized, Open-label, Two-way Crossover, Multi-institution Comparative Clinical Trial Evaluating the Safety and Efficacy of Cylinder Pump (Anyfusion® V-100) and Infusion Pump for Healthy Adult Volunteers

A Prospective, Randomized, Open-label, Two-way Crossover, Multi-institution Comparative Clinical Trial Evaluating the Safety and Efficacy of Cylinder Pump (Anyfusion® V-100) and Infusion Pump for Healthy Adult Volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0004580
Enrollment
44
Registered
2019-12-24
Start date
2017-11-20
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Meinntech
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.A healthy adult male who is 20 years old to 50 years old at the time of screening test. 2. A person who weighs more than 45kg and has a weight within ± 20% of the ideal body weight Ide ideal body weight (kg) = (height (cm)-100) × 0.9 3. Upon hearing and fully understanding the detailed description of the study, and voluntarily decided to participate and agree in writing to comply with the precautions of this study.

Exclusion criteria

Exclusion criteria: 1) Liver, Kidney, Nervous System, Respiratory System, Endocrine System, Immune System, Blood & Tumor, Mental Illness, Cardiovascular Disease or History 2) A person who shows any of the following results in a clinical laboratory test: -AST (SGOT) or ALT (SGPT)> 1.25 times the upper limit of normal range -Total bilirubin> 1.5 times the upper limit of normal range HGB <13 g / dL or> 17 g / dL, HCT <39% or> 52% -EGFR <60 mL / min / 1.73? calculated by MDRD formula eGFR (estimated glomerular filtration rate) (mL / min / 1.73?) -175 x [Serum Creatinine (mg / dL)]-1.154 x [Age] -0.203 Positive serologic test (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test) 3) After rest for 5 minutes or more, the vital signs measured at the left position show a value corresponding to systolic pressure> 150 mmHg or <90 mmHg, diastolic pressure> 100 mmHg, or <50 mmHg. 4) A person with a history of trypanophobia associated with drug or other clinically significant hypersensitivity reactions or injections 5) Those who have a history of drug abuse or have tested positive for drugs of abuse on urine drug screening 6) Those who drink continuously (greater than 210 g / week) or cannot drink during the clinical trial 7) A person who deems the investigator unsuitable for participation in the clinical trial due to the clinical laboratory test results and other reasons.

Design outcomes

Primary

MeasureTime frame
Convenience Global Assessment

Secondary

MeasureTime frame
Accuracy comparison;Convenience Global Assessment;Evaluation of performance(72 hours);Convenience Point-to-Point Comparison

Countries

Korea, Republic of

Contacts

Public ContactMin Park

Yonsei University Health System, Severance Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026