|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648934 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Topiramate Sprinkle Capsules 25 mg Drug: Topamax® Sprinkle Capsules 25 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fed Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers |
| Enrollment: | 36 |
| Study Start Date: | November 2005 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Topiramate Sprinkle Capsules 25 mg
|
Drug: Topiramate Sprinkle Capsules 25 mg
25mg, single dose fed
|
|
2: Active Comparator
Topamax® Sprinkle Capsules 25 mg
|
Drug: Topamax® Sprinkle Capsules 25 mg
25mg, single dose fed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female.
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullivan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | TOPR-0584 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00648934 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anti-Obesity Agents Therapeutic Uses Physiological Effects of Drugs Topiramate Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |