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

NCT02101866 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-05-30

No results posted yet for this study

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

DRUG

Vapendavir 300 mg tablet

tablet - single dose

DRUG

Vapendavir 132 mg capsules

2 capsules - single dose

Sponsors & Collaborators

  • Biota Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Matson, M.D. · Prism Research, Inc

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-05-31
Completion
2014-06-30

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 NCT02101866 on ClinicalTrials.gov