MedTrace Logo

Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product

NCT05083325 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-10-28

No results posted yet for this study

Summary

This study will investigate the bioavailability in fasting male and/or non-pregnant and non- breast feeding female subjects of 1 capsule formulation containing Oseltamivir Phosphate 75 mg.

The study will be performed at a single site with 36 subjects. Participants will take 1 capsule of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 2 days between each study period.

Conditions

  • Bioequivalence

Interventions

DRUG

Oseltamivir 75mg Test Drug capsules

Investigational Medicinal Product

DRUG

Oseltamivir 75mg capsules Reference Product capsules

Tamiflu (Roche Pharma (Switzerland) AG, Basel)

Sponsors & Collaborators

  • Laboratorios Andromaco S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2021-10-10
Completion
2021-10-10

Countries

  • India

Study Locations

More Related Trials

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 NCT05083325 on ClinicalTrials.gov