NCT04536415

Bioequivalence Study of Oseltamivir Phosphate and TAMIFLU Under Fed Condition in Healthy Volunteers

Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Oseltamivir Phosphate 75 mg Capsule of Yangtze River Pharmaceutical (Group) Co., Ltd., China and TAMIFLU® (Oseltamivir Phosphate) Capsules 75 mg of Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 in Healthy, Adult, Human Subjects Under Fed Condition

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Austarpharma, LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the bioequivalence of Oseltamivir Phosphate Capsules 75 mg versus TAMIFLU 75 mg capsules administered as 75 mg capsules in healthy volunteers under Fed condition.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Oseltamivir Phosphate 75 mg capsules	Capsules, 75 mg, single, oral dose
DRUG	Tamiflu capsules 75 mg	Capsules, 75 mg, single, oral dose

Timeline

• Start date: 2020-08-25
• Primary completion: 2020-08-27
• Completion: 2020-08-27
• First posted: 2020-09-02
• Last updated: 2023-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study