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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: Completed Phase 1 study of Seizures, sponsored by Roxane Laboratories.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Blood sampling taken during specified time points to determine bioequivalence

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
Roxane Laboratories

93 total trials

What the finished NCT01703468 record still lists

NCT01703468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 933-participant average among 39 other Seizures trials with a reported enrollment target (94% lower).

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 a single indexed study location in 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.

Similar trials for Seizures

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01703468's enrollment target sits among peer trials

59 24th of 39 higher than 16 of 39 other Seizures trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Seizures trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01703468, the US trial registry maintained by the National Library of Medicine. NCT01703468 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.