CClinicalTrials.gg
CompletedNCT00905346Updated Aug 20, 2024Results posted

Topiramate 25 mg Capsule Mixed With Applesauce Under Fasting Conditions

A Phase 1 interventional study of Topiramate 25 mg Capsules and Topamax® 25 mg Capsules 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 2024-08-20.

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

Phase
Phase 1
Study type
Interventional
Enrollment
24
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 or topiramate 25 mg capsules (test) versus Topamax® (reference) administered as the content of 2 x 25 mg capsules mixed with applesauce under fasting conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

02

Conditions studied

  • Healthy

Keywords

  • Bioequivalence
  • Healthy Subjects
03

In context

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
24 participants (actual)

Study arms

  • Experimental
    Test First

    Topiramate Capsules 25 mg

    Drug: Topiramate 25 mg Capsules · Other: Applesauce

  • Active comparator
    Reference First

    Topamax® 25 mg Capsule

    Drug: Topamax® 25 mg Capsules · Other: Applesauce

Interventions

  • DrugTopiramate 25 mg Capsules

    Topiramate Capsules 2 x 25 mg

  • DrugTopamax® 25 mg Capsules

    Topamax® Capsule 2 x 25 mg

  • OtherApplesauce

    Applesauce

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

    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
Started1212
Completed1112
Not completed10
Withdrew: Withdrawal by subject10
Period 2
Participant flow — Period 2
MilestoneTopiramate (Test) FirstTopamax® (Reference) First
Started1011
Completed1011
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 Concentration630.45 ± 165.68631.49 ± 158.97
Statistical analysis
  • Topiramate (Test) vs Topamax® Reference · Ratio of the ls mean (test/ref x 100): 98.39 · 90% CI 94.36 to 102.59Bioequivalence is established when 90% Confidence Interval 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)33225.68 ± 5455.2232576.20 ± 8063.83
Statistical analysis
  • Topiramate (Test) vs Topamax® Reference · Ratio of the ls mean (test/ref x 100): 102.92 · 90% CI 99.88 to 106.05Bioequivalence is established when 90% Confidence Interval falls within 80-125.
PrimaryAUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration

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
ng*hr/mLTopiramate (Test)Topamax® Reference
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration28199.89 ± 4966.8627731.63 ± 7139.70
Statistical analysis
  • Topiramate (Test) vs Topamax® Reference · Ratio of the ls mean (test/ref x 100): 102.63 · 90% CI 99.24 to 106.14Bioequivalence is established when 90% Confidence Interval falls within 80-125.

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Topiramate (Test) FirstTopamax® (Reference) FirstTotal
<=18 years000
Between 18 and 65 years121224
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Topiramate (Test) FirstTopamax® (Reference) FirstTotal
Female213
Male101121
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Topiramate (Test) FirstTopamax® (Reference) FirstTotal
Caucasian121224
Region of Enrollment
Region of Enrollment(participants)Topiramate (Test) FirstTopamax® (Reference) FirstTotal
Canada121224
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 Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00905346
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
Aug 20, 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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