NCT05297968

Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Oseltamivir Phosphate For Oral Suspension/Tamiflu	the subjects randomly received single oral administration of Oseltamivir Phosphate For Oral Suspension/Tamiflu 75mg (6mg/ml,12.5ml)
DRUG	Oseltamivir Phosphate For Oral Suspension	the subjects randomly received single oral administration of Oseltamivir Phosphate For Oral Suspension 75mg (6mg/ml,12.5ml)

Timeline

• Start date: 2021-05-13
• Primary completion: 2021-06-06
• Completion: 2021-06-27
• First posted: 2022-03-28
• Last updated: 2022-03-28

Locations

1 site across 1 country: China