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NCT00649974 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT00649974 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 28 participants.

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The verdict

NCT00649974, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

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 administered under fasting conditions.

Interventions

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

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2005-05
Est. Completion 2005-05
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00649974

The ClinicalTrials.gov registry entry for NCT00649974 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Valacyclovir Hydrochloride Tablets 1000 mg is the first listed.

NCT00649974 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00649974 about?

NCT00649974 is a clinical study titled "Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and 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 administered under fasting conditions.

What is the current status of trial NCT00649974?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2005-05. Estimated completion is 2005-05.

What interventions are being tested in trial NCT00649974?

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

Who is sponsoring clinical trial NCT00649974?

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

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.