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Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition

NCT02297854 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2014-11-21

No results posted yet for this study

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 Fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Valganciclovir Hydrochloride

Valganciclovir Hydrochloride Tablets 450 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Aplesh kumar Patel, 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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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 NCT02297854 on ClinicalTrials.gov