- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00850174
Oxcarbazepine 600 mg Tablets Under Fasting Conditions
September 9, 2009 updated by: Teva Pharmaceuticals USA
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Oxcarbazepine 600 mg Tablets Under Fasting Conditions
The objective of this study is to evaluate the comparative bioavailability between Oxcarbazepine 600 mg Tablets (test) and Trileptal® 600 mg Tablets (reference) after a single-dose in healthy subjects under fasting conditions.
Study Overview
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
Ontario
-
Toronto, Ontario, Canada, M1R 5A3
- Pharma Medica Research Inc.
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy, non-smoking male and female subjects, 18 years of age or older.
- BMI greater than or equal to 19 and less than or equal to 30.
Negative for:
- HIV.
- Hepatitis B surface antigen and Hepatitis C antibody.
- Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
- Urine cotinine test
- Serum HCG consistent with pregnancy (females only)
- No significant diseases or clinically significant findings in a physical examination.
- No clinically significant abnormal laboratory values.
- No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
- Be informed of the nature of the study and given written consent prior to receiving any study procedure.
Females who participate in this study are:
- unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy or,
- willing to remain abstinent [not engage in sexual intercourse] or,
- willing to use an effective method of double-barrier birth control [partner using condom and female using diaphragm, contraceptive sponge, spermicide or IUD].
- Females who participate in this study are not pregnant and/or non-lactating.
Exclusion Criteria:
- Known history or presence of any clinically significant medical condition.
- Known or suspected carcinoma.
Known history or presence of:
- Hypersensitivity or idiosyncratic reaction to oxcarbazepine and/or any other drug substances with similar activity.
- Alcoholism within the last 12 months.
- Drug dependence and/or substance abuse.
- Use of tobacco or nicotine-containing products within the last 6 months.
- On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
- Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
- Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
- Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
- Females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
- Requirement of any medication (prescription, hormonal contraceptive and/or over-the-counter) on a routine basis, with the exception of nutritional supplements and/or occasional use of common analgesics.
- Difficulty fasting or consuming the standard meals.
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
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oxcarbazepine
Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
|
600 mg Tablet
|
Active Comparator: Trileptal®
Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
|
600 mg Tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma
Time Frame: Blood samples collected over 48 hour period
|
Bioequivalence based on Cmax
|
Blood samples collected over 48 hour period
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine
Time Frame: Blood samples collected over 48 hour period
|
Bioequivalence based on AUC0-inf
|
Blood samples collected over 48 hour period
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine
Time Frame: Blood samples collected over 48 hour period
|
Bioequivalence based on AUC0-t
|
Blood samples collected over 48 hour period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax - 10-hydroxy-carbazepine in Plasma
Time Frame: Blood samples collected over 48 hour period
|
Results of Metabolite for Informational Purposes Only
|
Blood samples collected over 48 hour period
|
AUC0-inf - 10-hydroxy-carbazepine Metabolite
Time Frame: Blood samples collected over 48 hour period
|
Results of Metabolite for informational purposes only
|
Blood samples collected over 48 hour period
|
AUC0-t - 10-hydroxy-carbazepine Metabolite
Time Frame: Blood samples collected over 48 hour period
|
Results of metabolite for informational purposes only
|
Blood samples collected over 48 hour period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xueyu (Eric) Chen, MD, Pharma Medica Research, Inc.
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
April 1, 2005
Primary Completion (Actual)
May 1, 2005
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
February 20, 2009
First Submitted That Met QC Criteria
February 23, 2009
First Posted (Estimate)
February 24, 2009
Study Record Updates
Last Update Posted (Estimate)
September 15, 2009
Last Update Submitted That Met QC Criteria
September 9, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-917
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.
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