HealthyPhase 1NCT00838279

Lamotrigine 25 mg Chewable Tablets, Fasting

A Phase 1 study testing Lamotrigine 25 mg Chewable Tablets and Lamictal® 25 mg Chewable Tablets 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 lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg chewable dispersible tablets under fasting 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?: Lamotrigine 25 mg Chewable Tablets and Lamictal® 25 mg Chewable Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteCanada
Study dates: Feb 2002to Mar 2002
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

Subjects will be females and/or males, non-smokers, 18 years of age and older.
Female subjects will be post-menopausal or surgically sterilized.
Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago.
Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

Who cannot join

Clinically significant illnesses within 4 weeks of the administration of the study medication.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Any clinically significant abnormality found during medical screening.
Subjects with a history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
Abnormal laboratory tests judged clinically significant.

Show all 23Show fewer

Positive urine drug screen at screening.
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 90; or heart rate less than 50 bpm) at screening.
Subjects with BMI ≥ 30.0.
History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit - 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PVP) and crack) within 1 year of the screening visit.
Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
History of allergic reactions to lamotrigine.
Use of any drugs known to induce or inhibit drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine, valproic acid), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural products, vitamins, garlic as supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
Subjects who have dentures or braces.
Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follow: less than 300 mL of whole blood within 30 days; 300 mL to 500 mL of whole blood within 45 days; more than 500 mL of whole blood within 56 days.
Positive alcohol breath test at screening.
Subjects who have used tobacco in any form within 90 days preceding study drug administration.
Female subjects: breast-feeding subjects.
Female subjects: positive urine pregnancy test at screening.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Anapharm Inc.
Sainte-Foy, Quebec, GIV2K8

Other trials in Canada

About this study

Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Lamotrigine 25 mg Chewable Dispersible Tablets and Lamictal® 25 mg Chewable Dispersible Tablets in Healthy Subjects Under Fasting Conditions

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions: Healthy
Being tested: Lamotrigine 25 mg Chewable Tablets, Lamictal® 25 mg Chewable Tablets
Keywords: Bioequivalence, Healthy Subjects

What participants receive

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

Lamotrigine 25 mg Chewable TabletsDrug
2 x 25 mg, single-dose fasting
Lamictal® 25 mg Chewable TabletsDrug
2 x 25 mg, single-dose fasting

Study groups in NCT00838279
Study group	Role	What they receive
Lamotrigine	Experimental	Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period Receives: Drug: Lamotrigine 25 mg Chewable Tablets
Lamictal®	Active comparator	Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period Receives: Drug: Lamictal® 25 mg Chewable Tablets

What is being measured

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

Cmax - Maximum Observed Concentration
Bioequivalence basd on Cmax
Measured: Blood samples collected over 120 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Bioequivalence based on AUC0-inf
Measured: Blood samples collected over 120 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 120 hour period

Timeline

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

Feb 2002Mar 2002

First posted6 Feb 2009 (estimated)
Study startFeb 2002
Primary completionMar 2002
Study completionMar 2002

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00838279
Sponsor's protocol ID: 01303
Status last verified: Aug 2024
First submitted: 5 Feb 2009
Last updated: 19 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Lamotrigine 25 mg Chewable Dispersible Tablets and Lamictal® 25 mg Chewable Dispersible Tablets in Healthy Subjects Under Fasting Conditions
ClinicalTrials.gov ID: NCT00838279
Acronym / sponsor ID: 01303
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Feb 2002
Primary completion: Mar 2002 (actual)
Study completion: Mar 2002 (actual)
First posted: 6 Feb 2009 (estimated)
Results: Posted 4 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lamotrigine	Experimental	Drug: Lamotrigine 25 mg Chewable TabletsLamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
Lamictal®	Active comparator	Drug: Lamictal® 25 mg Chewable TabletsLamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects will be females and/or males, non-smokers, 18 years of age and older.
Female subjects will be post-menopausal or surgically sterilized.
Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago.
Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

Key exclusion criteria (23 listed)

Clinically significant illnesses within 4 weeks of the administration of the study medication.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Any clinically significant abnormality found during medical screening.
Subjects with a history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lamotrigine 25 mg Chewable Tablets2 x 25 mg, single-dose fasting	Drug	Lamotrigine
Lamictal® 25 mg Chewable Tablets2 x 25 mg, single-dose fasting	Drug	Lamictal®

Primary outcome

Cmax - Maximum Observed Concentration
Time frame: Blood samples collected over 120 hour period
Bioequivalence basd on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time frame: Blood samples collected over 120 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Time frame: Blood samples collected over 120 hour period
Bioequivalence based on AUC0-t

Results and safety

Results posted to the registry on 4 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lamotrigine (Test) First	16	16
Lamictal® (Reference) First	16	16

Primary outcome: Cmax - Maximum Observed Concentration

Time frame: Blood samples collected over 120 hour period. Mean (Standard Deviation). Unit: ng/mL

Measure	Lamotrigine n = 29	Lamictal® n = 29
Value	713.46 (95.02)	709.97 (84.37)

Lamotrigine vs Lamictal®: Test/Ref Ratio of LS Means x 100: 100.31 (90% CI 97.82 to 102.85)

Population analysed: Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.

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

Time frame: Blood samples collected over 120 hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Lamotrigine n = 29	Lamictal® n = 29
Value	34541.03 (14354.41)	33498.85 (12316.96)

Lamotrigine vs Lamictal®: Test/Ref Ratio of LS Means x 100: 101.78 (90% CI 99.09 to 104.55)

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

Time frame: Blood samples collected over 120 hour period. Mean (Standard Deviation). Unit: ng/mL

Measure	Lamotrigine n = 29	Lamictal® n = 29
Value	28843.06 (6866.12)	28923.66 (7355.31)

Lamotrigine vs Lamictal®: Test/Ref Ratio of LS Means x 100: 99.94 (90% CI 97.40 to 102.55)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric Bicrell, M.D. principal investigator

Anapharm

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lamotrigine 25 mg Chewable Tablets and Lamictal® 25 mg Chewable Tablets 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 4 inclusion and 23 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 4 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 (time frame: Blood samples collected over 120 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 NCT00838279.

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.