Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition
NCT02296723 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2014-11-20
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.
Conditions
- Healthy
Interventions
- DRUG
-
Valganciclovir Hydrochloride
Valganciclovir Hydrochloride Tablets 450 mg
Sponsors & Collaborators
-
Dr. Reddy's Laboratories Limited
lead INDUSTRY
Principal Investigators
-
Dr. Pankaj Kumar Jha, MD · Lambda Therapeutic Research Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-07-31
- Primary Completion
- 2011-07-31
- Completion
- 2011-08-31
Countries
- India
Study Locations
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