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CompletedNCT00904943Updated Sep 19, 2024Results posted

Topiramate 25 mg Capsules Under Fed Conditions

A Phase 1 interventional study of Topiramate Capsules, 25 mg and Topamax® Capsules, 25 mg in Healthy, sponsored by Teva Pharmaceuticals USA. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Teva Pharmaceuticals USA · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

02

Conditions studied

  • Healthy

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Keywords

  • Bioequivalence
  • Healthy Subjects
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 18 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Teva Pharmaceuticals USA is the lead sponsor of 171 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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).
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Test First

    Topiramate Capsules, 25 mg

    Drug: Topiramate Capsules, 25 mg

  • Active comparator
    Reference First

    Topamax® Capsules, 25 mg

    Drug: Topamax® Capsules, 25 mg

Interventions

  • DrugTopiramate Capsules, 25 mg

    2 x 25 mg Capsules

  • DrugTopamax® Capsules, 25 mg

    2 x 25 mg Capsules

06

What researchers measure

Primary outcomes

  1. Cmax - Maximum Observed Concentration

    Bioequivalence based on Cmax

    Time frame: Blood samples collected over 168 hour period

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

    Bioequivalence based on AUC0-inf

    Time frame: Blood samples collected over 168 hour period

  3. 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

    Time frame: Blood samples collected over 168 hour period

07

Results

Posted Sep 23, 2009

Participant flow

Period 1
Participant flow — Period 1
MilestoneTopiramate (Test) FirstTopamax® (Reference) First
Started99
Completed99
Not completed00
Period 2
Participant flow — Period 2
MilestoneTopiramate (Test) FirstTopamax® (Reference) First
Started98
Completed98
Not completed00

Outcome measures

PrimaryCmax - Maximum Observed Concentration

Bioequivalence based on Cmax

Time frame:
Blood samples collected over 168 hour period
Reported as:
Mean · ng/mL
Cmax - Maximum Observed Concentration
ng/mLTopiramate (Test)Topamax® (Reference)
Cmax - Maximum Observed Concentration573.29 ± 163.05550.55 ± 161.55
Statistical analysis
  • Topiramate (Test) vs Topamax® (Reference) · Ratio of the ls mean (test/ref x 100): 104.27Bioequivalence is established when Ratio of the Mean falls within 80-125.
PrimaryAUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf

Time frame:
Blood samples collected over 168 hour period
Reported as:
Mean · ng*hr/mL
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
ng*hr/mLTopiramate (Test)Topamax® (Reference)
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)34657.80 ± 8059.5633592.62 ± 7059.10
Statistical analysis
  • Topiramate (Test) vs Topamax® (Reference) · Ratio of the ls mean (test/ref x 100): 102.35Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.
PrimaryAUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t

Time frame:
Blood samples collected over 168 hour period
Reported as:
Mean · ng*hr/mL
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
ng*hr/mLTopiramate (Test)Topamax® (Reference)
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)30342.73 ± 7475.7629129.82 ± 6960.37
Statistical analysis
  • Topiramate (Test) vs Topamax® (Reference) · Ratio of the ls mean (test/ref x 100): 103.66Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Topiramate (Test) FirstTopamax® (Reference) FirstTotal
<=18 years000
Between 18 and 65 years9918
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Topiramate (Test) FirstTopamax® (Reference) FirstTotal
Female112
Male8816
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Topiramate (Test) FirstTopamax® (Reference) FirstTotal
Caucasian9817
Black011
Region of Enrollment
Region of Enrollment(participants)Topiramate (Test) FirstTopamax® (Reference) FirstTotal
Canada9918
08

Study locations

1 site
  • Anapharm Inc.
    Sainte-Foy, Quebec G1V 2K8, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00904943
Lead sponsor
Teva Pharmaceuticals USA
First posted
May 20, 2009
Start date
Jun 2002
Primary completion
Jul 2002
Completion
Jul 2002
Results posted
Sep 23, 2009
Last update
Sep 19, 2024

Study contacts

Benoit Girard, MD
principal investigator · Anapharm

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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