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NCT00649870 · ClinicalTrials.gov registry record · Phase 1

Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg

A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target
1
Study location

NCT00649870 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 26 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00649870, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target
1
Study location

Study Summary

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 administration under fed conditions.

Conditions Studied

Interventions

  • DRUG Valacyclovir Hydrochloride Tablets 1000 mg
  • DRUG Valtrex® Tablets 1000 mg

Study Locations (1)

West Virginia

  • Kendle International Inc. - Morgantown

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2005-05
Est. Completion 2005-06
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00649870

The ClinicalTrials.gov registry entry for NCT00649870 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Valacyclovir Hydrochloride Tablets 1000 mg is the first listed.

NCT00649870 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.

Frequently Asked Questions

What is clinical trial NCT00649870 about?

NCT00649870 is a clinical study titled "Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg". 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 administration under fed conditions.

What is the current status of trial NCT00649870?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2005-05. Estimated completion is 2005-06.

What conditions does trial NCT00649870 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00649870?

The interventions under investigation include: Valacyclovir Hydrochloride Tablets 1000 mg (DRUG), Valtrex® Tablets 1000 mg (DRUG).

Who is sponsoring clinical trial NCT00649870?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00649870 being conducted?

This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.