Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

• Status: Completed
• Trial end date: 2021-06-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Affiliated Hospital of Qingdao University
• Treatments: Oseltamivir

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