Official Title: “Steady-State Bioequivalence Study of Extended Phenytoin Sodium Capsules (100 mg; Mylan) and Dilantin® Kapseals® (100 mg; Pfizer) in Healthy Adult Volunteers”

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.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: December 2005

Intervention(s) in this Clinical Trial

• 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
• Drug: Dilantin® Kapseals® 100 mg
  • 3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Extended Phenytoin Sodium Capsules 100 mg
• Active Comparator: 2
  • Dilantin® Kapseals® 100 mg

Primary Measures

• Bioequivalence
  • Time Frame: within 30 days
    Safety Issue?: No

Inclusion Criteria:

• 1. Age: 18 years and older.
• 2. Sex: Male and/or females of non-childbearing potential.
• 1. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
• 1. postmenopausal with an absence of menses for at least one (1) year, or 2. bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or 3. total hysterectomy
• 2. During the course of the study, from study screen until study exit - including the washout period, men must use a spermicide containing barrier method of contraception. This advice should be documented in the informed consent form.
• 3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of their Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II
• ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
• 4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, Hepatitis B and Hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 21 days of the initial dose of study medication.

Exclusion Criteria:

• 1. Institutionalized subjects will not be used.
• 2. Social Habits:
• 1. Use of any tobacco-containing products within 1 year of the start of the study.
• 2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
• 3. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
• 4. Any recent, significant change in dietary or exercise habits.
• 5. A positive test for any drug included in the urine drug screen.
• 6. History of drug and/or alcohol abuse.
• 3. Medications:
• 1. Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
• 2. Use of any hormone replacement therapy within 3 months prior to study medication dosing.
• 3. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
• 4. Diseases:
• 1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
• 2. Acute illness at the time of either the pre-study medical evaluation or dosing.
• 3. A positive HIV, Hepatitis B, or Hepatitis C test.
• 4. History of porphyria.
• 5. History of diabetes.
• 5. Abnormal and clinically significant laboratory test results:
• 1. Clinically significant deviation from the Guide to Clinically Relevant
• Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
• 2. Abnormal and clinically relevant ECG tracing.
• 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
• 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
• 8. Allergy or hypersensitivity to phenytoin or any other hydantoins.
• 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
• 10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mylan Pharmaceuticals

Overall Clinical Trial Officials and Contacts

James D Carlson, Pharm. D. Principal Investigator PRACS Institute Ltd.  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00647621

Study ID Number: PHEN-0529

ClinicalTrials.gov Identifier: NCT00647621

Health Authority: United States: Institutional Review Board

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