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A Bioequivalence Study of Oseltamivir From Oseltamivir 75 mg Caps (Pharmacare PLC, Palestine) and Tamiflu® 75 mg Caps (Hoffmann-La Roche, Switzerland)

NCT02507648 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-07-24

No results posted yet for this study

Summary

Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Oseltamivir from Oseltamivir 75 mg capsules (Pharmacare PLC, Palestine) and Tamiflu® 75 mg capsules (Hoffmann-La Roche, Switzerland under license Gilead Sciences ,California ,USA after a single oral dose administration of each to healthy adults under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Oseltamivir

1 tablet contains 75 mg oseltamivir

DRUG

Tamiflu®

1 tablet contains 75 mg oseltamivir

Sponsors & Collaborators

  • Pharmacare PLC, Palestine

    collaborator UNKNOWN

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-03-31
Completion
2013-05-31

Countries

  • Egypt

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 NCT02507648 on ClinicalTrials.gov