Clinical trial NCT05297968: Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension
Official title: Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized,two-treatment,two-period,two-sequence
Primary purpose: TREATMENT

Brief summary: an open label,balanced,randomized,two-treatment,two-period,two-sequence,single dose,crossover,oral bioequivalence Study of oseltamivir phosphate for oral suspension in healthy ,adult,human subjects under fasted/fed conditions.

Detailed description: 72 healthy adult subjects will be enrolled and randomized in the study.In each period,total 21 venous blood samples (3ml each)will be collected at 0h，10min,20min,30min,45min,1h,1.25h,1.5h,1.75h,2h,2.25h,2.5h,3h,3.5h,4h,4.5h,5h,6h,8h,12h,24h,36h.

Eligibility criteria: Inclusion Criteria:

* 1) Subjects are able to give the signed ICF before the study, and fully understand the study content, process and possible adverse reactions; 2) Subjects are able to complete the study in compliance the study in compliance with the protocol; 3) Subjects (including male subjects) agree to adopt effective contraceptive methods and not plan to get pregnant or to donate sperm or ovum from 14 days before screening to 3 months after study completion; 4) Healthy male and female subjects above 18 years of age ( inclusive); 5) Male subjects who are at least 50 kg and female subjects who are at least 45 kg, with a Body Mass Index (BMI)= Weight/Height2 (kg/m2) between 19.0-26.0 kg/m2 (both inclusive);

Exclusion Criteria:

1. History of specific allergies (asthma, etc.), allergies (such as those who are allergic to two or more drugs, foods such as milk or pollen), or hypersensitivity to Oseltamivir Phosphate or any excipients or related class of drugs
2. People with rare hereditary galactose intolerance or fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase deficiency;
3. No history of cardiac, hepatic, renal, digestive tract, nervous system, mental and metabolic disorders, etc.;
4. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption;
5. History of surgery within 3 months prior to first dosing;
6. 5 or more cigarettes per day on average within 3 months before the screening;
7. Use of any drugs within 14 days prior to dosing

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to 1 year
measure: Area under the plasma concentration versus time curve (AUC0-t)
timeFrame: up to 1 year
measure: Area under the plasma concentration versus time curve (AUC0-∞)
timeFrame: up to 1 year
measure: Bioequivalence
timeFrame: up to 1 year
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase I Clinical Research Center
state: Shandong
Study officials:
affiliation: the study director of phase I clinical research center
name: yu Cao, Dr
role: PRINCIPAL_INVESTIGATOR
References: