Oxcarbazepine 600 mg Tablets Under Fasting Conditions

NCT00850174 | Completed Phase 1 Results

• 1 other identifier: 2005-917
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma

  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

  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

  Bioequivalence based on AUC0-t

  Blood samples collected over 48 hour period

Secondary Outcomes (3)

• Cmax - 10-hydroxy-carbazepine in Plasma

  Blood samples collected over 48 hour period

• AUC0-inf - 10-hydroxy-carbazepine Metabolite

  Blood samples collected over 48 hour period

• AUC0-t - 10-hydroxy-carbazepine Metabolite

  Blood samples collected over 48 hour period

Study Arms (2)

Oxcarbazepine

EXPERIMENTAL

Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period

Drug: Oxcarbazepine

Trileptal®

ACTIVE COMPARATOR

Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period

Drug: Trileptal®

Interventions

Oxcarbazepine DRUG

600 mg Tablet

Oxcarbazepine

Trileptal® DRUG

600 mg Tablet

Trileptal®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Pharma Medica Research Inc.

Toronto, Ontario, M1R 5A3, Canada

Location

MeSH Terms

Interventions

Oxcarbazepine

Intervention Hierarchy (Ancestors)

Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Xueyu (Eric) Chen, MD

  Pharma Medica Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 24, 2009
• Study Start: April 1, 2005
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: August 19, 2024
• Results First Posted: August 18, 2009

Record last verified: 2024-08

Locations

CA (1)