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

NCT04536415 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-02-02

No results posted yet for this study

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

DRUG

Oseltamivir Phosphate 75 mg capsules

Capsules, 75 mg, single, oral dose

DRUG

Tamiflu capsules 75 mg

Capsules, 75 mg, single, oral dose

Sponsors & Collaborators

  • Austarpharma, LLC

    lead INDUSTRY

Principal Investigators

  • Tejas Talati, MBBS · Veeda Clinical Research Pvt. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2020-08-27
Completion
2020-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04536415 on ClinicalTrials.gov