HealthyPhase 1NCT00905567

Topiramate 25 mg Tablets Under Fed Conditions

A Phase 1 study testing Topiramate 2 x 25 mg tablet and Topamax® Tablet 2 x 25 mg 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 was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets 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?: Topiramate 2 x 25 mg tablet and Topamax® Tablet 2 x 25 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteCanada
Study dates: Jun 2001to Jun 2001
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 or older
Subjects should read, sign and date an Informed Consent Form prior to any study procedures.
Female subjects will be post-menopausal or surgically sterilized.
Post menopausal status is defined as absence of menses for the past 12 months or bilateral oophorectomy at least 6 months ago or hysterectomy with bilateral oophorectomy at least 6 months ago.
Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation aat least 6 months ago.

Who cannot join

Clinically significant illnesses within 4 weeks of the administration of study medication.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Any history or presence of significant neurological, hepatic, renal, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
Any clinically significant abnormality found during medical screening.
Abnormal laboratory tests judged clinically significant.
Positive urine drug screen at screening.

Show all 21Show fewer

Positive alcohol breath test at screening.
Subjects who use tobacco in any form will not be eligible to participate in this study. Three months abstinence is required.
Positive testing for hepatitis B, hepatitis C or HIV at screening.
ECG or vital sign abnormalities (clinically significant).
Subjects with BMI greater than or equal to 30.0.
History of significant alcohol abuse within 6 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 (PCP) and crack) within 1 year of the screening visit.
Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subjects participation in this study.
History of allergic reactions to topiramate.
Use of any drugs known to induce or inhibit hepatic drug metabolism, 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 within 7 days prior to administration of study medication, except for topical products without systemic absorption.
Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (500 mL) within 56 days prior to administration of the study medication.
Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
Additional exclusion criteria for females only:
Positive urine pregnancy test at screening (performed on all females).

Trial locations and contacts

1 site in 1 country.

Canada1 site

Anapharm Inc.
Sainte-Foy, Quebec, G1V 2K8

Other trials in Canada

About this study

Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Tablets Administered as 2 x 25 mg Tablets in Healthy Subjects Under Fed Conditions

The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fed conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions: Healthy
Being tested: Topiramate 2 x 25 mg tablet, Topamax® Tablet 2 x 25 mg
Keywords: Bioequivalence, Healthy Subjects

What participants receive

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

Topiramate 2 x 25 mg tabletDrug
Topamax® Tablet 2 x 25 mgDrug

Study groups in NCT00905567
Study group	Role	What they receive
Test First	Experimental	Topiramate 2 x 25 mg Tablet Receives: Drug: Topiramate 2 x 25 mg tablet
Reference First	Active comparator	Topamax® Tablet 2 x 25 mg Receives: Drug: Topamax® Tablet 2 x 25 mg

What is being measured

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

Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax
Measured: Blood samples collected over 96 hour period
AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)
Bioequivalence based on AUC0-72
Measured: Blood samples collected over 96 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 96 hour period

Timeline

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

Jun 2001Jun 2001

First posted20 May 2009 (estimated)
Study startJun 2001
Primary completionJun 2001
Study completionJun 2001

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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00905567
Sponsor's protocol ID: 01178
Status last verified: Aug 2009
First submitted: 18 May 2009
Last updated: 23 Sep 2009
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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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Tablets Administered as 2 x 25 mg Tablets in Healthy Subjects Under Fed Conditions
ClinicalTrials.gov ID: NCT00905567
Acronym / sponsor ID: 01178
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Jun 2001
Primary completion: Jun 2001 (actual)
Study completion: Jun 2001 (actual)
First posted: 20 May 2009 (estimated)
Results: Posted 23 Sep 2009

Clinical summary

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

The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fed conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study design

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

Arm	Type	Receives
Test First	Experimental	Drug: Topiramate 2 x 25 mg tabletTopiramate 2 x 25 mg Tablet
Reference First	Active comparator	Drug: Topamax® Tablet 2 x 25 mgTopamax® Tablet 2 x 25 mg

Who may qualify

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

Key inclusion criteria (5 listed)

Subjects will be females and/or males, non-smokers, 18 years of age or older
Subjects should read, sign and date an Informed Consent Form prior to any study procedures.
Female subjects will be post-menopausal or surgically sterilized.
Post menopausal status is defined as absence of menses for the past 12 months or bilateral oophorectomy at least 6 months ago or hysterectomy with bilateral oophorectomy at least 6 months ago.
Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation aat least 6 months ago.

Key exclusion criteria (21 listed)

Clinically significant illnesses within 4 weeks of the administration of study medication.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Any history or presence of significant neurological, hepatic, renal, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
Any clinically significant abnormality found during medical screening.
Abnormal laboratory tests judged clinically significant.

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
Topiramate 2 x 25 mg tablet	Drug	Test First
Topamax® Tablet 2 x 25 mg	Drug	Reference First

Primary outcome

Cmax - Maximum Observed Concentration
Time frame: Blood samples collected over 96 hour period
Bioequivalence based on Cmax
AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)
Time frame: Blood samples collected over 96 hour period
Bioequivalence based on AUC0-72
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 96 hour period
Bioequivalence based on AUC0-t

Results and safety

Results posted to the registry on 23 Sep 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
Topiramate (Test) First	12	12
Topamax® (Reference) First	12	12

Primary outcome: Cmax - Maximum Observed Concentration

Time frame: Blood samples collected over 96 hour period. Mean (Standard Deviation). Unit: ng/mL

Measure	Topiramate n = 23	Topamax® n = 23
Value	633.96 (251.55)	700.79 (310.12)

Topiramate vs Topamax®: Ratio of the Least Squares Mean: 93.01

Population analysed: Data from all subjects who completed the study was included in statistical analysis.

Primary outcome: AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)

Time frame: Blood samples collected over 96 hour period. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Topiramate n = 23	Topamax® n = 23
Value	20792.34 (7701.94)	21930.92 (9118.60)

Topiramate vs Topamax®: Ratio of the Least Squares Mean: 96.62

Population analysed: Data from all subjects who completed the study was included in the statistical analysis.

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 96 hour period. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Topiramate n = 23	Topamax® n = 23
Value	23634.03 (8515.55)	24918.64 (9927.37)

Topiramate vs Topamax®: Ratio of the Least Squares Mean: 96.43

Population analysed: Data from all subjects who completed the study was used in the statistical analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2009.
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.

Benoit Girard, MD 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 Topiramate 2 x 25 mg tablet and Topamax® Tablet 2 x 25 mg 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 5 inclusion and 21 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 23 Sep 2009. 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 23 Sep 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 96 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 NCT00905567.

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 23 Sep 2009.