Completed

Bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg in Fasted Conditions

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This phase 1 study aims to determine the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg by comparing its maximum concentration in the bloodstream under fasted conditions.

What is being tested

Oxcarbazepine

+ Oxcarbazepine

Drug
Who is being recruted

Nervous System Diseases+2

+ Neurologic Manifestations

+ Signs and Symptoms

From 18 to 45 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2009
See protocol details

Summary

Principal SponsorRoxane Laboratories
Last updated: January 23, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2009

Actual date on which the first participant was enrolled.

This study focuses on comparing two versions of a medication called Oxcarbazepine Suspension 600 mg, one of which is developed by Roxane Laboratories. The goal is to check if these two versions work equally well in the body when taken on an empty stomach. This research is important as it helps ensure that different versions of the same medicine provide the same benefits, addressing a key challenge in healthcare. The study is designed for adults who can safely take this medication. During the study, participants receive a single dose of each version of the medication at different times, with a break in between. The effects of these doses are then compared. The main aspect being evaluated is how much of the medication reaches the bloodstream, which helps determine if both versions are equally effective. This study follows a strict protocol to ensure safety and accuracy of results.

NCT01702623
Principal SponsorRoxane Laboratories
Last updated: January 23, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

64 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSeizures

Criteria

1 inclusion criteria required to participate
No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
3 exclusion criteria prevent from participating
History of allergic or adverse response to oxcarbazepine or any comparable or similar product
Positive test for HIV, Hepatitis B, or Hepatitis C
Treatment with known enzyme altering drugs

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period)

Group II

Active Comparator
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

San Antonio, United StatesOpen Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research) in Google Maps
CompletedOne Study Center