Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-05-31

Brief Summary

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The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

Valacyclovir Hydrochloride Tablets 1000 mg

Group Type EXPERIMENTAL

Valacyclovir Hydrochloride Tablets 1000 mg

Intervention Type DRUG

1000mg, single dose fasting

2

Valtrex® Tablets 1000 mg

Group Type ACTIVE_COMPARATOR

Valtrex® Tablets 1000 mg

Intervention Type DRUG

1000mg, single dose fasting

Interventions

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Valacyclovir Hydrochloride Tablets 1000 mg

1000mg, single dose fasting

Intervention Type DRUG

Valtrex® Tablets 1000 mg

1000mg, single dose fasting

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes