Influenza Clinical Trial
Official title:
A Single-center, Randomized, Double-blind, Placebo-controlled and Single-center, Randomized, Open, Double-crossed Food Impact Trial to Evaluate the Safety, Tolerability, Pharmacokineticof GP681 Tablets in Healthy Subjects
Verified date | August 2020 |
Source | Jiangxi Qingfeng Pharmaceutical Co. Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Influenza (influenza for short) is an acute respiratory infectious disease caused by influenza virus. The symptoms of the disease range from mild, moderate to severe, and severe cases require hospitalization and may die. According to estimates by the US Centers for Disease Control and Prevention in 2018, influenza causes approximately 290,000 to 640,000 deaths worldwide each year. Therefore, the prevention and treatment of influenza has become a serious public health problem.
Status | Completed |
Enrollment | 56 |
Est. completion date | December 15, 2020 |
Est. primary completion date | December 15, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 18-45 years old, male or female (the food impact test is limited to males); male =50 kg, female =45kg,BMI19-26; Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements. Exclusion Criteria: - history of allergies, allergic diseases or allergies to drugs in research; medical history of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc. or other diseases that are not suitable for participating in clinical trials (such as mental illness history, etc.); donated blood or blood loss = 400 mL within 3 months before enrollment; |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Xuhui Central Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Jiangxi Qingfeng Pharmaceutical Co. Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic parameter | Peak concentration (Cmax) | 12 days | |
Primary | ncidence of adverse events as a measure of safety and tolerability | Observed side effects and alteration in laboratory values. | 12 days | |
Primary | area under the drug-time curve | area under the drug-time curve (AUC0-t, AUC0-8) | 12 days |
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