Status:
COMPLETED
Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Healthy Subjects
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 un...
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,2.2...
Eligibility Criteria
Inclusion
- 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
- 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
- People with rare hereditary galactose intolerance or fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase deficiency;
- No history of cardiac, hepatic, renal, digestive tract, nervous system, mental and metabolic disorders, etc.;
- History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption;
- History of surgery within 3 months prior to first dosing;
- 5 or more cigarettes per day on average within 3 months before the screening;
- Use of any drugs within 14 days prior to dosing
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05297968
Start Date
May 13 2021
End Date
June 27 2021
Last Update
March 28 2022
Active Locations (1)
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1
Phase I Clinical Research Center
Qingdao, Shandong, China, 266003