NCT02101866

A Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Formulations in Healthy Volunteers

A Randomized, Single-Center, Open-Label, Two-Period, Two-Sequence, Crossover, Comparative Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Product Formulations in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Biota Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 study aims to determine the oral bioavailability of a single dose of a new vapendavir tablet formulation and compare it to that of the previous vapendavir capsule formulation. The safety of both drug products will also be assessed.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Vapendavir 300 mg tablet	tablet - single dose
DRUG	Vapendavir 132 mg capsules	2 capsules - single dose

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2014-04-02
• Last updated: 2018-05-30

Locations

1 site across 1 country: United States