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NCT00650494 · ClinicalTrials.gov registry record · Phase 1
Fed Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg
A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT00650494 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 66 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00650494, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 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 GSK'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 1000mg
- DRUG Valtrex® 1000 mg
Study Locations (1)
West Virginia
- Kendle International Inc. - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2005-08 |
| Est. Completion | 2005-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00650494
The ClinicalTrials.gov registry entry for NCT00650494 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 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 (90% 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 1000mg is the first listed.
NCT00650494 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.
Frequently Asked Questions
What is clinical trial NCT00650494 about?
NCT00650494 is a clinical study titled "Fed 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 GSK'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 NCT00650494?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2005-08. Estimated completion is 2005-08.
What conditions does trial NCT00650494 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00650494?
The interventions under investigation include: Valacyclovir Hydrochloride Tablets 1000mg (DRUG), Valtrex® 1000 mg (DRUG).
Who is sponsoring clinical trial NCT00650494?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00650494 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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.