NCT01703468

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2012

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

October 5, 2012

Last Update Submit

January 19, 2018

Conditions

Seizures

Outcome Measures

Primary Outcomes (1)

  • bioequivalence determined by statistical comparison Cmax

    Blood sampling taken during specified time points to determine bioequivalence

    10 days

Study Arms (2)

Oxcarbazepine then Trileptal

ACTIVE COMPARATOR

600 mg suspension

Drug: Oxcarbazepine

Trileptal then Oxcarbazepine

ACTIVE COMPARATOR

600 mg suspension

Drug: Oxcarbazepine

Interventions

OxcarbazepineDRUG
Also known as: Trileptal
Oxcarbazepine then TrileptalTrileptal then Oxcarbazepine

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

You may not qualify if:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to oxcarbazepine or any comparable or similar product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Seizures

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CarbamazepineDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Cynthia Zamora, MD

    Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2012

First Posted

October 10, 2012

Study Start

September 1, 2009

Primary Completion

September 1, 2009

Study Completion

October 1, 2009

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)