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HealthyPhase 1NCT00849797

Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions

A Phase 1 study testing Oxcarbazepine and Trileptal® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Oxcarbazepine and Trileptal®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteCanada
Study dates
Jul 2005to Jul 2005
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female, smoker or non-smoker, 18 years of age and older.
  • BMI greater than or equal to 19.0 and less than or equal to 30.0 kg/m2

Who cannot join

  • Subjects to whom any of the following applies will be excluded from the study:
  • Clinically significant illnesses or surgery within 4 weeks of the administration of study medication.
  • Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
  • Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
  • Positive testing for hepatitis B, hepatitis C or HIV at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90mmHg; or heart rate less than 50 or over 100 bpm) at screening.
Show all 33Show fewer
  • History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
  • Regular use of alcohol within six months prior to the screening visit (more than 14 units of alcohol per [1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of 40% alcohol], or positive alcohol breath test at screening.
  • Use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
  • History of allergic reactions to heparin, oxcarbazepine, carbamazepine, or other related drugs.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to the administration of the study medication.
  • Use of an investigational drug or participation on an investigation study within 30 days prior to dosing.
  • Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
  • Any clinically significant history or presence or neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Difficulty to swallow study medication.
  • Smoking more than 25 cigarettes per day.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
  • A depot injection or an implant of any drug within 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 30 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
  • 50 mL to 300 mL of whole blood within 30 days or
  • 301 mL to 500 mL of whole blood within 45 days or
  • more than 500 mL of whole blood within 56 days.
  • Consumption of food or beverages containing grapefruit (e.g. fresh, canned or frozen) within 7 days prior to administration of the study medication.
  • History or presence of atreoventricular (AV) block.
  • Difficulty fasting or consuming the standard meals.
  • Intolerance to venipunctures.
  • Clinically significant history of renal, hepatic, or cardiovascular, tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
  • Positive urine pregnancy test at screening.
  • Breast-feeding subject.
  • Female subjects of child-bearing potential having unprotected sexual intercourse with any non-sterile male partner within 14 days prior to study drug administration. Acceptable methods of contraception:
  • Intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration.
  • Condom or diaphragm + spermicide.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • SFBC Anapharm

    Montreal, Quebec, H3X 2H9

Other trials in Canada

About this study

Official title: Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Oxcarbazepine 600 mg Tablet and Trileptal® Following a 600 mg Dose in Healthy Subjects Under Fed Conditions

The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions
Healthy
Being tested
Oxcarbazepine, Trileptal®
Keywords
Bioequivalence, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxcarbazepineDrug

    600 mg Tablet

  • Trileptal®Drug

    600 mg Tablet

Study groups in NCT00849797
Study groupRoleWhat they receive
OxcarbazepineExperimentalOxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
Receives: Drug: Oxcarbazepine
Trileptal®Active comparatorTrileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
Receives: Drug: Trileptal®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma

    Bioequivalence based on Cmax

    Measured: Blood samples collected over 48 hour period

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

    Bioequivalence based on AUC0-inf

    Measured: Blood samples collected over 48 hour period

  3. 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

    Measured: Blood samples collected over 48 hour period

Secondary outcomes (3)

  1. Cmax - 10-hydroxy-carbazepine in Plasma

    Informational Purposes Only

    Measured: Blood samples collected over 48 hour period

  2. AUC0-inf - 10-Hydroxy-Carbazepine Metabolite

    Informational Purposes Only

    Measured: Blood samples collected over 48 hour period

  3. AUC0-t - 10-Hydroxy-Carbazepine Metabolite

    Informational Purposes Only

    Measured: Blood samples collected over 48 hour period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2009 (estimated)
  2. Study startJul 2005
  3. Primary completionJul 2005
  4. Study completionJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00849797
Sponsor's protocol ID
50370
Status last verified
Aug 2024
First submitted
20 Feb 2009
Last updated
19 Aug 2024
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oxcarbazepine and Trileptal® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma (time frame: Blood samples collected over 48 hour period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00849797.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.

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