Influenza Clinical Trial
Official title:
A Single-Center, Randomized, Double-Blind, Single and Multiple Doses, Placebo-Controlled Study,To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Food Effects of HEC116094HCl•3H2O and the Interaction With Oseltamivir Phosphate Capsules in Chinese Healthy Subjects
Verified date | April 2023 |
Source | Sunshine Lake Pharma Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Safety, Tolerability, Pharmacokinetic, Food Effect Study and the interaction with Oseltamivir Phosphate Capsules of HEC116094 in Healthy Subjects
Status | Completed |
Enrollment | 118 |
Est. completion date | October 2, 2022 |
Est. primary completion date | October 2, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study. - Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication. - When signing the informed consent, 18 years old =the age=45 years old(including the critical value), gender is not limited. - Male body weight =50kg, female body weight =45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value). - No clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results. Exclusion Criteria: - Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis. - Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations. - Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. - Positive results from urine drug screen test. - Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing. - Subjects who plan to receive or have had organ transplants. - Subjects considered by the investigator to have other factors unsuitable for participation in this study. |
Country | Name | City | State |
---|---|---|---|
China | The Shanghai xuhui district central hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Sunshine Lake Pharma Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Tolerability of HEC116094 by Assessment of the Number of Adverse | To investigate the safety and tolerability of HEC116094 by assessment of AEs | up to 7 days at Part A and 11 days at Part B and 26 days at Part C | |
Secondary | Cmax | Maximum Plasma Concentration(Cmax)of HEC116094 | up to 72 hours | |
Secondary | AUC | Area Under the Curve(AUC) of HEC116094 | up to 72 hours | |
Secondary | Tmax | Maximum Peak Time(Tmax) of HEC116094 | up to 72 hours | |
Secondary | T1/2 | Maximum Peak Time(Tmax) of HEC116094 | up to 72 hours |
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