Status and phase
Conditions
Treatments
About
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.
Full description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Enrollment
Sex
Ages
Volunteers
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:
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:
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:
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.
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal