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Oxcarbazepine 600 mg Tablets Under Fasting Conditions

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Oxcarbazepine (Drug); Trileptal® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Xueyu (Eric) Chen, MD, Principal Investigator, Affiliation: Pharma Medica Research, Inc.

Summary

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.

Clinical Details

Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Oxcarbazepine 600 mg Tablets Under Fasting Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine

Secondary outcome:

Cmax - 10-hydroxy-carbazepine in Plasma

AUC0-inf - 10-hydroxy-carbazepine Metabolite

AUC0-t - 10-hydroxy-carbazepine Metabolite

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pharma Medica Research Inc., Toronto, Ontario M1R 5A3, Canada
Additional Information

Starting date: April 2005
Last updated: September 9, 2009

Page last updated: August 23, 2015

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