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
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.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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 →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.
Exclusion Criteria:
Additional exclusion criteria for females only:
Topiramate Capsules, 25 mg
Drug: Topiramate Capsules, 25 mg
Topamax® Capsules, 25 mg
Drug: Topamax® Capsules, 25 mg
2 x 25 mg Capsules
2 x 25 mg Capsules
Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax
Time frame: Blood samples collected over 168 hour period
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
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
| Milestone | Topiramate (Test) First | Topamax® (Reference) First |
|---|---|---|
| Started | 9 | 9 |
| Completed | 9 | 9 |
| Not completed | 0 | 0 |
| Milestone | Topiramate (Test) First | Topamax® (Reference) First |
|---|---|---|
| Started | 9 | 8 |
| Completed | 9 | 8 |
| Not completed | 0 | 0 |
Bioequivalence based on Cmax
| ng/mL | Topiramate (Test) | Topamax® (Reference) |
|---|---|---|
| Cmax - Maximum Observed Concentration | 573.29 ± 163.05 | 550.55 ± 161.55 |
Bioequivalence based on AUC0-inf
| ng*hr/mL | Topiramate (Test) | Topamax® (Reference) |
|---|---|---|
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | 34657.80 ± 8059.56 | 33592.62 ± 7059.10 |
Bioequivalence based on AUC0-t
| ng*hr/mL | Topiramate (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 ± 7475.76 | 29129.82 ± 6960.37 |
| Age, Categorical(Participants) | Topiramate (Test) First | Topamax® (Reference) First | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 9 | 18 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Topiramate (Test) First | Topamax® (Reference) First | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 8 | 8 | 16 |
| Race/Ethnicity, Customized(Participants) | Topiramate (Test) First | Topamax® (Reference) First | Total |
|---|---|---|---|
| Caucasian | 9 | 8 | 17 |
| Black | 0 | 1 | 1 |
| Region of Enrollment(participants) | Topiramate (Test) First | Topamax® (Reference) First | Total |
|---|---|---|---|
| Canada | 9 | 9 | 18 |
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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Teva Pharmaceuticals USA