NCT01258530

A Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers

A Randomized, Open-label, Single-Dose, Two-Period, Crossover Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a study in healthy adult volunteers to assess the bioequivalence of over-encapsulated oseltamivir capsules to commercially available oseltamivir capsules. Both formulations will be administered in the fasting state.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DRUG	over-encapsulated oseltamivir	75 mg once
DRUG	oseltamivir	75 mg once

Timeline

• Start date: 2010-12-20
• Primary completion: 2011-02-03
• Completion: 2011-02-03
• First posted: 2010-12-13
• Last updated: 2017-06-07

Locations

1 site across 1 country: United States