A Multicenter, placebo-controlled single blind, dose-escalation, Investigator initiated trial for seven days repeated intravenous administration of NK-104-NP to healthy adult male volunteers for seven days

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2015
INTERVENTION: NK‐104‐NP 2 mg/body NK‐104‐NP 4 mg/body NK‐104‐NP 8 mg/body CONDITION: Pulmonary Hypertension PRIMARY OUTCOME: Safety: Names, severity and frequency of adverse effect and adverse drug reactions.; Pharmacokinetics: Concentrations of pitavastatin and pitavastatin lactone SECONDARY OUTCOME: Change of physiological functions (body temparature, blood pressure, plus SPO2),change of laboratory evidences, change of a chest X‐ray examination and change of cardiac functions. INCLUSION CRITERIA: 1)Healthy Male Japanese 2)A person aged 20yo to 40yo 3)A person with a BMI values under 18.5 or over 30.0
Epistemonikos ID: 2affdb4666f9fb8d8183664835acf4717d62cc5a
First added on: Aug 23, 2024