NCT01728753

T-705a Multicenter Study in Adults Subjects With Uncomplicated Influenza

Randomized, Double Blind,Placebo-Controlled, Multicenter Study Evaluating the Safety and Pharmacokinetics of Different Dosing Regimens of Favipiravir in Healthy Adult Subjects and Adult Subjects With Uncomplicated Influenza

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: MDVI, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is safety and pharmacokinetics (PK) of favipiravir study in adults 18-80 years of age diagnosed with uncomplicated influenza.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Placebo	Placebo BID x 1 day, and Placebo BID x 4 days; Placebo TID x 1 day, and Placebo TID x 4 days
DRUG	Favipiravir	1200 mg TID on Day 1, then 600 mg TID on Days 2-5
DRUG	Favipiravir	2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5
DRUG	Favipiravir	1800 mg BID on Day 1, then 800mg BID for Days 2 5

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-11-20
• Last updated: 2015-10-21

Locations

1 site across 1 country: United States