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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00647621 |
Purpose
The objective of this study was to investigate the steady-state bioequivalence of Mylan's extended phenytoin sodium capsules, 100mg (3x100mg), to Pfizer's Dilantin® Kapseals®, 100mg (3x100mg), under both fasting and fed conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Extended Phenytoin Sodium Capsules 100 mg Drug: Dilantin® Kapseals® 100 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Steady-State Bioequivalence Study of Extended Phenytoin Sodium Capsules (100 mg; Mylan) and Dilantin® Kapseals® (100 mg; Pfizer) in Healthy Adult Volunteers |
| Enrollment: | 72 |
| Study Start Date: | October 2005 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Extended Phenytoin Sodium Capsules 100 mg
|
Drug: Extended Phenytoin Sodium Capsules 100 mg
3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16
|
|
Active Comparator: 2
Dilantin® Kapseals® 100 mg
|
Drug: Dilantin® Kapseals® 100 mg
3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or females of non-childbearing potential.
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, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58104 | |
| Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
More Information
| Responsible Party: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00647621 History of Changes |
| Other Study ID Numbers: | PHEN-0529 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Phenytoin Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |