NCT02296723

Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition

Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Cross Over, Single Dose, Oral Bioequivalence Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fed conditions.

Detailed description

Open label, balanced, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of Valganciclovir Hydrochloride Tablets 450 mg under Fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Valganciclovir Hydrochloride	Valganciclovir Hydrochloride Tablets 450 mg

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-07-01
• Completion: 2011-08-01
• First posted: 2014-11-20
• Last updated: 2014-11-20

Locations

1 site across 1 country: India