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Neuraminidase Inhibitor

Oseltamivir Phosphate 75 mg capsules (Yangtze River) for Bioequivalence

Phase 4

Waitlist Available

Led By Tejas Talati, MBBS

Research Sponsored by Austarpharma, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial compares two flu medications, Oseltamivir Phosphate and TAMIFLU, to see if they are equally effective when taken by healthy people after a meal. Oseltamivir, also known as TAMIFLU, has been widely studied and used for the treatment and prevention of influenza, showing significant efficacy in reducing the duration and incidence of flu symptoms.

Eligible Conditions

Bioequivalence

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC)

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Oseltamivir Phosphate 75 mg capsules (Yangtze River)Experimental Treatment1 Intervention

During the study session, healthy participants will be administered a single dose of Oseltamivir Phosphate capsules 75 mg of Yangtze River Pharmaceutical (Group) Co., Ltd., China under Fed condition.

Group II: Tamiflu capsules 75 mg (Genentech, Inc.)Active Control1 Intervention

During the study session, healthy participants will be administered a single dose of Tamiflu capsules 75 mg of Genentech, Inc. under Fed condition.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oseltamivir

FDA approved

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