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NCT01703468 · ClinicalTrials.gov registry record · Phase 1

Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

A Phase 1 study of Seizures, sponsored by Roxane Laboratories.

Completed
Registry status
Phase 1
Development phase
59
Enrollment target
1
Study location

NCT01703468 is a Phase 1 study of Seizures that has completed, run by Roxane Laboratories. The registered enrollment target is 59 participants, below the 933-participant average among 39 other Seizures trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01703468, a Phase 1 study of Seizures, has completed, sponsored by Roxane Laboratories.

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

Study Summary

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fed conditions

Conditions Studied

Interventions

  • DRUG Oxcarbazepine

Study Locations (1)

Texas

  • Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research) - San Antonio

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2009-09
Est. Completion 2009-10
Phase Phase 1

Sponsor

Roxane Laboratories

93 total trials

What the Registry Record Tells You About NCT01703468

The ClinicalTrials.gov registry entry for NCT01703468 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 933-participant average among 39 other Seizures trials with a reported enrollment target (94% lower). The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Seizures appearing as the primary indexed condition, and to 1 intervention - of which Oxcarbazepine is the first listed.

NCT01703468 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT01703468 about?

NCT01703468 is a clinical study titled "Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions". The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fed conditions

What is the current status of trial NCT01703468?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2009-09. Estimated completion is 2009-10.

What conditions does trial NCT01703468 study?

This clinical trial studies the following conditions: Seizures.

What interventions are being tested in trial NCT01703468?

The interventions under investigation include: Oxcarbazepine (DRUG).

Who is sponsoring clinical trial NCT01703468?

This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01703468 being conducted?

This trial has 1 study location across Texas. 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.