- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01702623
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
January 19, 2018 updated by: Roxane Laboratories
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fasted conditions.
Study Overview
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78217
- Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oxcarbazepine first, then Trileptal
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period)
|
Other Names:
|
Active Comparator: Trileptal first, then Oxcarbazepine
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
bioequivalence determined by statistical comparison Cmax
Time Frame: 10 Days
|
10 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
October 4, 2012
First Submitted That Met QC Criteria
October 5, 2012
First Posted (Estimate)
October 8, 2012
Study Record Updates
Last Update Posted (Actual)
January 23, 2018
Last Update Submitted That Met QC Criteria
January 19, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OXCA-S600-PVFS-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Seizures
-
Eisai Inc.CompletedPartial Onset Seizures | Primary Generalized Tonic-Clonic Seizures | Secondarily Generalized SeizuresUnited States
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedGeneralized Tonic Clonic SeizuresKorea, Republic of, United States, Austria, Serbia, India, Spain, Poland, Malaysia, China, Bulgaria, Denmark, Greece, Hungary, United Kingdom, Belarus, France, Montenegro, Philippines, Romania, Russian Federation, Slovakia, Ukraine, Lebano... and more
-
Lundbeck LLCCompletedAdult Refractory Complex Partial SeizuresUnited States
-
University Hospital, BordeauxCompletedPsychogenic Nonepileptic Seizures (PNESs)France
-
Xenon Pharmaceuticals Inc.Worldwide Clinical TrialsRecruitingPrimary Generalized Tonic-Clonic SeizuresUnited States, Australia, Bulgaria, Poland, Czechia, Canada, Portugal, Croatia, Italy, Spain
-
UCB Biopharma SRLRecruitingStereotypical Prolonged SeizuresUnited States, Bulgaria, China, Czechia, Germany, Hungary, Italy, Japan, Poland, Spain, United Kingdom, France, Australia
-
Central Hospital, Nancy, FranceCompletedPsychogenic Non-epileptic SeizuresFrance
-
UCB Biopharma SRLEnrolling by invitationStereotypical Prolonged SeizuresUnited States, Bulgaria, China, Czechia, Germany, Hungary, Italy, Japan, Poland, Spain, United Kingdom, Australia
-
ValexfarmCompletedEpilepsy | Complex Partial Seizures | Simple Partial Seizures | Partial Seizures With Secondary GeneralizationRussian Federation
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedEpilepsy, Partial Seizures | Epilepsy, Primary Generalized Tonic-Clonic SeizuresUnited States, Korea, Republic of, Taiwan, Lebanon, Singapore, Malaysia, China, Spain, Bulgaria, Czechia, United Kingdom, Israel, Russian Federation, France, Belarus, Belgium, Bosnia and Herzegovina, Germany, Greece, Hungary, India and more
Clinical Trials on Oxcarbazepine
-
Collaborative Care Initiative, LLCDauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen...UnknownBipolar Depression | Treatment Effectiveness | Measure-based GuidanceUnited States
-
Desitin Arzneimittel GmbHFGK Clinical Research GmbHTerminated
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Prostate Cancer FoundationCompleted
-
Novartis PharmaceuticalsCompleted
-
Novartis PharmaceuticalsCompleted
-
Supernus Pharmaceuticals, Inc.CompletedSafety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial EpilepsyPartial EpilepsyUnited States, Poland, Bulgaria, Romania, Canada, Russian Federation, Mexico, Croatia
-
Supernus Pharmaceuticals, Inc.Approved for marketing
-
Ranbaxy Laboratories LimitedCompleted
-
Supernus Pharmaceuticals, Inc.CompletedEpilepsies, PartialUnited States
-
Ranbaxy Laboratories LimitedCompleted